Identity
- Trade Name
- epic edge FDA UDI
- Generic Name
- Nylon suture, non-bioabsorbable, monofilament FDA UDI
- Device Name
- 10/0 BL Mono Nylon, 10 cm length, 1/2 cir Spatula Ndl, Single Arm (single device) FDA UDI
- Model / Reference
- N2674 FDA UDI
- Description
- 10/0 BL Mono Nylon, 10 cm length, 1/2 cir Spatula Ndl, Single Arm (single device) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855019008000 FDA UDI
- FDA Product Code
- GAR FDA UDI
- GMDN Term
- Nylon suture, non-bioabsorbable, monofilament FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5020 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Length — 10 Centimeter FDA UDI
Category: Nylon suture, non-bioabsorbable, monofilament
epic edge by R.k. Manufacturing Corporation Of Connecticut — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- DemeLON — DemeTECH Corp · Class II
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
- R.k. Manufacturing Corporation Of Connecticut
Sources (1)
- FDA UDI 42b13fd6-72a1-42b4-8e9b-5e23a519e628 36 fields · synced Jun 1, 2026