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Osseoguard®

FDA UDI

Class II (US FDA UDI)

by Biomet 3i, Llc

Identity

Trade Name
OSSEOGUARD® FDA UDI
Generic Name
Polytetrafluoroethylene suture FDA UDI
Device Name
OSSEOGUARD® PTFE SUTURE USP 4-0 13MM 1/2 CIRCLE ROUND BODY TAPER POINT FDA UDI
Model / Reference
OS4013PE FDA UDI
Description
OSSEOGUARD® PTFE SUTURE USP 4-0 13MM 1/2 CIRCLE ROUND BODY TAPER POINT FDA UDI

Identifiers

Primary DI / UDI-DI
00844868041498 FDA UDI
FDA Product Code
NBY FDA UDI
GMDN Term
Polytetrafluoroethylene suture FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5035 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 18 Inch FDA UDI

Category: Polytetrafluoroethylene suture

Osseoguard® by Biomet 3i, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polytetrafluoroethylene suture.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomet 3i, Llc

Sources (1)

  • FDA UDI 55cf65d6-495d-4d6d-a5b5-3103d4925122 36 fields · synced Jun 8, 2026