Identity
- Trade Name
- Bioviva by 3D Dental FDA UDI
- Generic Name
- Catgut suture, chromic FDA UDI
- Device Name
- Bioviva Suture Chromic Gut 3/0 27",Taper Point,1/2, 18mm RB1 Needle Single FDA UDI
- Model / Reference
- SCG204-1 FDA UDI
- Description
- Bioviva Suture Chromic Gut 3/0 27",Taper Point,1/2, 18mm RB1 Needle Single FDA UDI
Identifiers
- Catalog Number
- SCG204-1 FDA UDI
- Primary DI / UDI-DI
- 00810126506580 FDA UDI
- FDA Product Code
- GAL FDA UDI
- GMDN Term
- Catgut suture, chromic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4830 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Bioviva by 3D Dental by 3d Dental Designs And Development, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- 3d Dental Designs And Development, Llc
Sources (1)
- FDA UDI db4d0a55-6bf1-406e-b4ff-f5abfb136c1c 35 fields · synced May 31, 2026