Identity
- Trade Name
- BioX-C™ Plug FDA UDI
- Generic Name
- General oral wound dressing, animal-derived FDA UDI
- Device Name
- "BioX-C™ Plug Resorbable Collagen - 10mm x 20mm" FDA UDI
- Model / Reference
- BIOX-CP FDA UDI
- Description
- "BioX-C™ Plug Resorbable Collagen - 10mm x 20mm" FDA UDI
Identifiers
- Catalog Number
- BIOX-CP FDA UDI
- Primary DI / UDI-DI
- 10841307123590 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
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: General oral wound dressing, animal-derived
BioX-C™ Plug by Implant Direct Sybron Manufacturing Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General oral wound dressing, animal-derived.
- OUSIA bioPLUG — ACE SURGICAL SUPPLY CO., INC. · Class II
- HealiAid Dental Collagen Wound Dressing — MAXIGEN BIOTECH INC. · U
- RCF Resorbable Collagen Foam — ACE SURGICAL SUPPLY CO., INC. · Class II
- 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 242e2db8-ee9e-4565-8ded-9f51abbe3127 37 fields · synced May 30, 2026