Data / Medical devices / Peru / Unilene, Sac

Unilene, Sac: FDA-registered device maker in Lima Lima(Region), Peru, 2 510(k) clearances

Name: Unilene, Sac FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Unilene, Sac is registered with the FDA (registration 3004845555) in Lima Lima(Region), Peru. It lists 11 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 28, 2013. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004845555
Address: Napo No. 450, Lima Lima(Region), Peru, 15082
Owner or operator: Unilene, SAC (10035000)
Roles: Manufacturer
First device listed: January 25, 2011
Registered through: 2026
Brand names listed: Medical Mask - Sutumed, Gamed, U-Mask, Cirugia Peruana, Monofilament Nylon - Synthetic Nonabsorbable Suture Sutumed, Vital Sutures, Suturex, Cirugia Peruana Plus, Oxygen Mask Sutumed, Gamed, U-Mask, Cirugia Peruana, Polydioxanone - Synthetic Absorbable Suture Sutumed, Vital Sutures, Suturex, Cirugia Peruana Plus, Polyglactin - Synthetic Absorbable Suture Sutumed, Vital Sutures, Suturex, Cirugia Peruana Plus, Polyglecaprone - Synthetic Absorbable Suture Sutumed, Vital Sutures, Suturex, Cirugia Peruana Plus, Polyglicolic Acid - Synthetic Absorbable Suture Sutumed, Vital Sutures, Suturex, Cirugia Peruana Plus, Polypropylene - Synthetic Nonasorbable Suture Sutumed, Vital Sutures, Suturex, Cirugia Peruana Plus and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Manufacturer	accessdata.fda.gov
Device, Rebreathing	BYW	1	Manufacturer	accessdata.fda.gov
Mask, Oxygen	BYG	1	Manufacturer	accessdata.fda.gov
Mask, Oxygen, Low Concentration, Venturi	BYF	1	Manufacturer	accessdata.fda.gov
Shield, Protective, Personnel	KPY	1	Manufacturer	accessdata.fda.gov
Suture, Absorbable, Synthetic	GAN	2	Manufacturer	accessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic Acid	GAM	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Silk	GAP	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyamide	GAR	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polypropylene	GAW	2	Manufacturer	accessdata.fda.gov
Suture, Surgical, Absorbable, Polydioxanone	NEW	2	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
May 28, 2013	K123034	VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED	GAR	Substantially Equivalent	Unilene Sac	accessdata.fda.gov
December 14, 2010	K100780	VITAL SUTURES, SUTUREX, CIRUGIA PERUANA	NEW	Substantially Equivalent	Unilene Sac	accessdata.fda.gov

Compare with other makers

Updated May 28, 2013. 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.