Identity
- Trade Name
- GUIDOR FDA UDI
- Generic Name
- Pliable-polymer dental regeneration membrane, bioabsorbable, ligated FDA UDI
- Device Name
- GUIDOR® Bioresorbable Matrix Barrier FDA UDI
- Model / Reference
- 5000 FDA UDI
- Description
- GUIDOR® Bioresorbable Matrix Barrier FDA UDI
Identifiers
- Catalog Number
- MC FDA UDI
- Primary DI / UDI-DI
- 00070942000031 FDA UDI
- FDA Product Code
- NPK FDA UDI
- GMDN Term
- Pliable-polymer dental regeneration membrane, bioabsorbable, ligated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3930 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
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Height — 15 Millimeter FDA UDIWidth — 19.8 Millimeter FDA UDI
Guidor by Sunstar Americas, Inc. — 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
- Sunstar Americas, Inc.
Sources (1)
- FDA UDI da924ec2-89ea-4fae-af4e-73d76cb0e4bc 38 fields · synced May 31, 2026