Identity
- Trade Name
- DemeLENE FDA UDI
- Generic Name
- Polyolefin/fluoropolymer suture, monofilament FDA UDI
- Device Name
- Synthetic, Monofilament , Nonabsorbable Suture FDA UDI
- Model / Reference
- PM198010F4P FDA UDI
- Description
- Synthetic, Monofilament , Nonabsorbable Suture FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10652927401599 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
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Polyolefin/fluoropolymer suture, monofilament
A comprehensive 2-3 paragraph SEO description written in clear, natural language. This device is a synthetic, nonabsorbable suture used for soft-tissue wound approximation and ligamentation. It provides temporary support until the wound heals, and is not a barbed suture. The product is sterile, labeled as no NRL, and available for commercial distribution.
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
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
- DemeTECH Corp
Sources (1)
- FDA UDI b5a1025b-901f-4092-ad27-9710cf0bf1ca 36 fields · synced Oct 7, 2026