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Biomet®

FDA UDI

Class II (US FDA UDI)

by Biomet Biologics, LLC

Identity

Trade Name
Biomet® FDA UDI
Generic Name
Open-surgery adhesive/sealant applicator, dual-channel FDA UDI
Model / Reference
800-0270 FDA UDI

Identifiers

Catalog Number
800-0270 FDA UDI
Primary DI / UDI-DI
00880304484757 FDA UDI
510(k) Number
K091722 FDA UDI
FDA Product Code
FMF FDA UDI
GMDN Term
Open-surgery adhesive/sealant applicator, dual-channel FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5860 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

Category: Open-surgery adhesive/sealant applicator, dual-channel

Biomet® by Biomet Biologics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Open-surgery adhesive/sealant applicator, dual-channel.

Cleared under the same submission

K091722 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomet Biologics, LLC

Sources (1)

  • FDA UDI b999edf1-6d56-4413-8fb9-bb21355b5c53 35 fields · synced Jun 1, 2026