DemeLENE

FDA UDI

Class II (US FDA UDI)

by DemeTECH Corp

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: PM259200,65A24 FDA UDI
Description: Synthetic (Polypropylene), Non Absorbable Suture FDA UDI

Identifiers

Primary DI / UDI-DI: 10652927256212 FDA UDI
FDA Product Code: OCW FDA UDI
GMDN Term: Polyolefin/fluoropolymer suture, monofilament FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 185 Centimeter 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

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 c29db6aa-101c-47cc-806b-470e77ef3a33 34 fields · synced Jun 1, 2026