Data / Medical devices / China / Derma Sciences Nantong Incorporation

Derma Sciences Nantong Incorporation: FDA-registered device maker in DEVELOPMENT Jiangsu, China, 7 510(k) clearances

Name: Derma Sciences Nantong Incorporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Derma Sciences Nantong Incorporation is registered with the FDA (registration 3003636207) in DEVELOPMENT Jiangsu, China. It lists 19 device types. The FDA files 7 510(k) clearances under its listings, the newest dated August 13, 1999. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3003636207
Address: No. 24 Tongzhou Road, Nantong Economic And Technological, DEVELOPMENT Jiangsu, China, JIANGSU
Owner or operator: GENTELL (10026501)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer
First device listed: September 2, 2008
Registered through: 2027
Brand names listed: 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, 59221 Pak-Its Gauze Plain Packing Strips Size 1/2" x 5 yd, 59245 Pak-Its Gauze Iodoform Packing Strips with Strip Delivery System Size 1/2" x 5 yd, 59246 Pak-Its Gauze IodoformPacking Strips Size 1/2" x 5 yd and more

Devices it lists

Device	Product code	Class	Role	Source
Anoscope And Accessories	FER	2	Manufacturer	accessdata.fda.gov
Bandage, Cast	ITG	1	Contract manufacturer	accessdata.fda.gov
Bandage, Elastic	FQM	1	Contract manufacturer	accessdata.fda.gov
Bandage, Liquid	KMF	1	Contract manufacturer	accessdata.fda.gov
Device, Intravascular Catheter Securement	KMK	1	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	MGQ	U	Contract manufacturer, Manufacturer	accessdata.fda.gov
Dressing, Wound And Burn, Occlusive	MGP	U	Contract manufacturer	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Contract manufacturer	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Manufacturer	accessdata.fda.gov
Gauze/Sponge, Internal	EFQ	U	Contract manufacturer, Manufacturer	accessdata.fda.gov
Gauze/Sponge, Internal, X-Ray Detectable	GDY	1	Contract manufacturer	accessdata.fda.gov
Instrument, Cast Removal, Ac-Powered	LGH	1	Manufacturer	accessdata.fda.gov
Pad, Eye	HMP	1	Manufacturer	accessdata.fda.gov
Strip, Adhesive, Closure, Skin	FPX	1	Contract manufacturer	accessdata.fda.gov
Suture Removal Kit	MCZ	1	Contract manufacturer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Manufacturer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Contract manufacturer	accessdata.fda.gov
Wound Dressing With Animal-Derived Material(S)	KGN	U	Contract manufacturer	accessdata.fda.gov

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
August 13, 1999	K990180	BURNFREE (4X4, 8X8, 16X24) STERILE BURN & WOUND DRESSING	MGQ	Substantially Equivalent	Nortrade Medical, Inc.	accessdata.fda.gov
August 13, 1999	K990179	BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD	MGQ	Substantially Equivalent	Nortrade Medical, Inc.	accessdata.fda.gov
August 13, 1999	K990178	BURNFREE PAIN RELIEVING GEL, MODEL 4B	MGQ	Substantially Equivalent	Nortrade Medical, Inc.	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
January 24, 1995	K946326	DUTEX GAUZE BANDAGE	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

Compare with other makers

Updated August 13, 1999. 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.