Bio-XC™ Foam

FDA UDI

Class U (US FDA UDI)

by Implant Direct Sybron Manufacturing Llc

Identity

Trade Name: Bio-XC™ Foam FDA UDI
Generic Name: General oral wound dressing, animal-derived FDA UDI
Device Name: "Bio-XC™ Foam Resorbable Collagen - 20mm x 40mm, 3 mm Thickness" FDA UDI
Model / Reference: BIO-XCF FDA UDI
Description: "Bio-XC™ Foam Resorbable Collagen - 20mm x 40mm, 3 mm Thickness" FDA UDI

Identifiers

Catalog Number: BIO-XCF FDA UDI
Primary DI / UDI-DI: 10841307123699 FDA UDI
FDA Product Code: KGN FDA UDI
GMDN Term: General oral wound dressing, animal-derived FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: General oral wound dressing, animal-derived

Bio-XC™ Foam by Implant Direct Sybron Manufacturing Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as General oral wound dressing, animal-derived.

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Symbios® Collagen Tape — Dentsply Implants Manufacturing GmbH · U
creos™ — Integra Lifesciences Corp. · Class III
CollaPlug® — Integra Lifesciences Corp. · Class III
RCT Resorbable Collagen Tape — ACE SURGICAL SUPPLY CO., INC. · Class II
GIBSON HEALTHCARE — BENCO DENTAL SUPPLY CO. · U

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class U	Pending data

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Manufacturer

Manufacturer: Implant Direct Sybron Manufacturing Llc

Sources (1)

FDA UDI e5cc164e-7246-4416-8a83-d41f103682c2 37 fields · synced Jun 8, 2026