Identity
- Trade Name
- SUTUMED FDA UDI
- Generic Name
- Nylon suture, non-bioabsorbable, monofilament FDA UDI
- Model / Reference
- SDNN010MC360 FDA UDI
Identifiers
- Catalog Number
- SDNN010MC360 FDA UDI
- Primary DI / UDI-DI
- 07757093013891 FDA UDI
- 510(k) Number
- K123034 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
Yes
FDA UDI
Category: Nylon suture, non-bioabsorbable, monofilament
Sutumed by Unilene Sac — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nylon suture, non-bioabsorbable, monofilament.
- DemeLON — DemeTECH Corp · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- DemeLON — DemeTECH Corp · Class II
- DemeLON — DemeTECH Corp · Class II
- SUPRAMID — S. Jackson, Inc. · Class II
- ETHILON — Ethicon Inc. · Class II
- UNIFY Nylon Surgical Sutures — APPLIED DENTAL, INC. · Class II
- DemeLON — DemeTECH Corp · Class II
Cleared under the same submission
K123034 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Unilene Sac
Sources (1)
- FDA UDI 13009242-04ac-493d-b2fe-c88628d984c1 35 fields · synced May 31, 2026