Data / Medical devices / Canada / Derma Sciences Canada, Inc
Derma Sciences Canada, Inc: FDA-registered device maker in TORONTO Ontario, Canada, 17 510(k) clearances
Derma Sciences Canada, Inc is registered with the FDA (registration 9680091) in TORONTO Ontario, Canada. It lists 22 device types. The FDA files 17 510(k) clearances under its listings, the newest dated June 27, 2008. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9680091
- FEI number
- 3002806830
- Address
- 104 Shorting RD., TORONTO Ontario, Canada, M1S 3S4
- Owner or operator
- GENTELL (10026501)
- Roles
- Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
- First device listed
- September 2, 2008
- Registered through
- 2027
- Brand names listed
- 40-2979 - Hydrogel Dressing, 53022 Aquasite Impregnated Gauze Size 2" x 2", 53048 Aquasite Impregnated Gauze Size 4" x 8", 59120 Pak-Its Gauze Plain Packing Strips with Strip Delivery System Size 1/4" x 5 yd, 59121 Pak-Its Gauze Plain Packing Strips Size 1/4" x 5 yd, 59145 Pak-Its Gauze Iodoform Packing Strips with Strip Delivery System Size 1/4" x 5 yd, 59146 Pak-Its Gauze Iodoform Packing Strips Size 1/4" x 5 yd, 59220 Pak-Its Gauze Plain Packing Strips with Strip Delivery System Size 1/2" x 5 yd and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 27, 2008 | K080497 | DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG) | FRO | Substantially Equivalent | Derma Sciences Canada, Inc. | accessdata.fda.gov |
| April 20, 2000 | K992732 | STERILE WATER & STERILE 0.9% SODIUM CHLORIDE | FOZ | Substantially Equivalent | Dumex Medical Surgical Products, Ltd. | accessdata.fda.gov |
| May 20, 1998 | K980861 | DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL | MGQ | Substantially Equivalent | Dumex Medical Surgical Products, Ltd. | accessdata.fda.gov |
| April 29, 1998 | K980791 | DUMEX PAK-ITS WOVEN RIBBON PACKING | EFQ | Substantially Equivalent | Dumex Medical Surgical Products, Ltd. | accessdata.fda.gov |
| April 29, 1996 | K960815 | DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL | NAD | Substantially Equivalent | Dumex Medical Surgical Products, Ltd. | accessdata.fda.gov |
| November 2, 1995 | K954743 | DERMAGRAN WOUND DRESSING CLEANER W/ZINC | FRO | Substantially Equivalent | Derma Sciences, Inc. | accessdata.fda.gov |
| November 2, 1995 | K954739 | DERMAGRAN HYDROPHILIC OINTMENT | FRO | Substantially Equivalent | Derma Sciences, Inc. | accessdata.fda.gov |
| November 2, 1995 | K954738 | DERMAGRAN HYDROPHILIC WOUND DRESSING | MGP | Substantially Equivalent | Derma Sciences, Inc. | accessdata.fda.gov |
| March 1, 1995 | K950132 | DUMEX WET DRESSINGS | FRO | Substantially Equivalent for Some Indications | Dumex Medical Surgical Products, Ltd. | accessdata.fda.gov |
| February 27, 1995 | K945802 | DERMAGRAN WOUND CLEANSER WITH ZINC | KMF | Substantially Equivalent | Derma Sciences, Inc. | accessdata.fda.gov |
| January 24, 1995 | K946326 | DUTEX GAUZE BANDAGE | EFQ | Substantially Equivalent | Dumex Medical Surgical Products, Ltd. | accessdata.fda.gov |
| January 11, 1995 | K945830 | DUFLEX CONFORMING BANDAGE (STERILE/NON-STERILE) | EFQ | Substantially Equivalent | Dumex Medical Surgical Products, Ltd. | accessdata.fda.gov |
| January 21, 1993 | K921291 | INMAN MEDICAL PACKING STRIP | FER | Substantially Equivalent | Inman Medical Corp. | accessdata.fda.gov |
| November 23, 1992 | K921290 | INMAN MEDICAL OIL EMULSION DRESSING | FRO | Substantially Equivalent for Some Indications | Inman Medical Corp. | accessdata.fda.gov |
| November 10, 1992 | K921289 | INMAN MEDICAL PETROLATUM DRESSING | FRO | Substantially Equivalent | Inman Medical Corp. | accessdata.fda.gov |
| June 17, 1992 | K914746 | DERMAGRAN WET DRESSING | MGQ | Substantially Equivalent | Derma Sciences, Inc. | accessdata.fda.gov |
| July 25, 1989 | K894205 | TECNOL SILK STRIP | FPX | Substantially Equivalent | Tecnol New Jersey Wound Care, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Drug
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- All makers of Tape, Measuring, Rulers And Calipers
Updated June 27, 2008. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.