BioPlug BioHorizons - 20mm x 10mm

FDA UDI

Class U (US FDA UDI)

by NovaBone Products, LLC

Identity

Trade Name: BioPlug BioHorizons - 20mm x 10mm FDA UDI
Generic Name: General oral wound dressing, animal-derived FDA UDI
Device Name: Collagen wound dressing FDA UDI
Model / Reference: BH2200 FDA UDI
Description: Collagen wound dressing FDA UDI

Identifiers

Catalog Number: BH2200 FDA UDI
Primary DI / UDI-DI: 00813909010250 FDA UDI
510(k) Number: K142712 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

Dimensions & Sizes

Size: Width — 10 Millimeter FDA UDI
Length — 20 Millimeter FDA UDI

Category: General oral wound dressing, animal-derived

BioPlug BioHorizons - 20mm x 10mm by NovaBone Products, 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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creos™ — Integra Lifesciences Corp. · Class III
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RCT Resorbable Collagen Tape — ACE SURGICAL SUPPLY CO., INC. · Class II
GIBSON HEALTHCARE — BENCO DENTAL SUPPLY CO. · U

Cleared under the same submission

K142712 also covers:

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: NovaBone Products, LLC

Sources (1)

FDA UDI dbdc99e2-2960-4000-9058-97aa68247a89 37 fields · synced Jun 9, 2026