Identity
- Trade Name
- OUSIA bioPLUG FDA UDI
- Generic Name
- General oral wound dressing, animal-derived FDA UDI
- Device Name
- OUSIA bioPLUG Collagen Plug 10MM X 20MM 10/BOX FDA UDI
- Model / Reference
- OUSPGEU FDA UDI
- Description
- OUSIA bioPLUG Collagen Plug 10MM X 20MM 10/BOX FDA UDI
Identifiers
- Catalog Number
- OUSPGEU FDA UDI
- Primary DI / UDI-DI
- 00614950028665 FDA UDI
- FDA Product Code
- LYC FDA UDI
- GMDN Term
- General oral wound dressing, animal-derived FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3930 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General oral wound dressing, animal-derived
OUSIA bioPLUG by Ace Surgical Supply Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General oral wound dressing, animal-derived.
- HealiAid Dental Collagen Wound Dressing — MAXIGEN BIOTECH INC. · U
- Symbios® Collagen Tape — Dentsply Implants Manufacturing GmbH · U
- creos™ — Integra Lifesciences Corp. · Class III
- CollaPlug® — Integra Lifesciences Corp. · Class III
- GIBSON HEALTHCARE — BENCO DENTAL SUPPLY CO. · U
- Curagen collagen wound dressing — MAXIGEN BIOTECH INC. · U
- HealiAid Dental Collagen Wound Dressing — MAXIGEN BIOTECH INC. · U
- NeoGen Plug — COLLAGEN MATRIX, INC. · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Ace Surgical Supply Co., Inc.
Sources (1)
- FDA UDI 312b0946-e24d-4f8a-b147-7a4f39ac68f9 35 fields · synced Jun 8, 2026