Identity
- Trade Name
- Darby Dental Supply, LLC FDA UDI
- Generic Name
- Polyglycolic acid suture FDA UDI
- Device Name
- SUTURE SYN ABS 3/8 NSF-2 5/0 18" DARBY FDA UDI
- Model / Reference
- 391A-DAR FDA UDI
- Description
- SUTURE SYN ABS 3/8 NSF-2 5/0 18" DARBY FDA UDI
Identifiers
- Catalog Number
- 9506239 FDA UDI
- Primary DI / UDI-DI
- 00889813003794 FDA UDI
- FDA Product Code
- GAM FDA UDI
- GMDN Term
- Polyglycolic acid suture FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4493 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polyglycolic acid suture
Darby Dental Supply, LLC by Darby Dental Supply, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Darby Dental Supply, Llc
Sources (1)
- FDA UDI 01616f28-23e1-47d0-8ed6-2062aaef99c5 36 fields · synced Jun 8, 2026