Identity
- Trade Name
- DemeLENE FDA UDI
- Generic Name
- Polyolefin/fluoropolymer suture, monofilament FDA UDI
- Device Name
- Synthetic (polypropylene), Non Absorbable Suture FDA UDI
- Model / Reference
- PM1095017F0P FDA UDI
- Description
- Synthetic (polypropylene), Non Absorbable Suture FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10652927265177 FDA UDI
- 510(k) Number
- K043330 FDA UDI
- FDA Product Code
- GAW FDA UDI
- GMDN Term
- Polyolefin/fluoropolymer suture, monofilament FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5010 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
Category: Polyolefin/fluoropolymer suture, monofilament
DemeLENE by DemeTECH Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyolefin/fluoropolymer suture, monofilament.
- SUTUMED — Unilene Sac · Class II
- ATRAMAT — Internacional Farmacéutica S.A DE C.V · Class II
- WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc. · Class II
- Premilene — B BRAUN SURGICAL SA · Class II
- DEKNATEL — TELEFLEX INCORPORATED · Class II
- GORE-TEX Suture Oral Health — W. L. GORE & ASSOCIATES, INC · Class II
- WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc. · Class II
- PROLENE — Ethicon Inc. · Class II
Cleared under the same submission
K043330 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
- DemeTECH Corp
Sources (1)
- FDA UDI e7e8a3a8-6897-40cd-a223-f5b31469bfc1 36 fields · synced Jun 8, 2026