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BioGlue Surgical Adhesive

FDA UDI

Class III (US FDA UDI)

by Artivion, Inc.

Identity

Trade Name
BioGlue Surgical Adhesive FDA UDI
Generic Name
Open-surgery adhesive/sealant applicator, dual-channel FDA UDI
Device Name
BioGlue Surgical Adhesive Syringe Spreader Tips FDA UDI
Model / Reference
BGST-12 FDA UDI
Description
BioGlue Surgical Adhesive Syringe Spreader Tips FDA UDI

Identifiers

Catalog Number
BGST-12 FDA UDI
Primary DI / UDI-DI
00877234000188 FDA UDI
PMA Number
P010003 FDA UDI
FDA Product Code
MUQ FDA UDI
GMDN Term
Open-surgery adhesive/sealant applicator, dual-channel FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
Not 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

BioGlue Surgical Adhesive by Artivion, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

P010003 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Artivion, Inc.

Sources (1)

  • FDA UDI 19b4f109-ade8-4d42-b8c3-b28c6de22636 39 fields · synced May 30, 2026