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Biosyn

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
Biosyn FDA UDI
Generic Name
Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI
Device Name
Monofilament Absorbable Suture,GS-26,Loop,1x Violet Strand FDA UDI
Model / Reference
CM-779L FDA UDI
Description
Monofilament Absorbable Suture,GS-26,Loop,1x Violet Strand FDA UDI

Identifiers

Primary DI / UDI-DI
10884521104136 FDA UDI
510(k) Number
K000037 FDA UDI
FDA Product Code
GAM FDA UDI
GMDN Term
Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4493 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 60 Inch FDA UDI

Category: Polyester suture, bioabsorbable, monofilament, non-antimicrobial

Biosyn by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyester suture, bioabsorbable, monofilament, non-antimicrobial.

Cleared under the same submission

K000037 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI 153ab4ef-7b57-4571-a724-6f561770d175 37 fields · synced May 30, 2026