Deknatel

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: DEKNATEL FDA UDI
Generic Name: Cardiovascular patch, synthetic FDA UDI
Device Name: POLYLENE GREEN 3-0 DS18 1N 45 CENTIMETER FDA UDI
Model / Reference: IPN029034 FDA UDI
Description: POLYLENE GREEN 3-0 DS18 1N 45 CENTIMETER FDA UDI

Identifiers

Catalog Number: E13-6338 FDA UDI
Primary DI / UDI-DI: 14026704637437 FDA UDI
FDA Product Code: GAT FDA UDI
GMDN Term: Cardiovascular patch, synthetic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.5000 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

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Length — 45 Centimeter FDA UDI

Category: Cardiovascular patch, synthetic

Deknatel by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiovascular patch, synthetic.

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Impra® ePTFE Cardiovascular Patch — Bard Peripheral Vascular · Class II
GORE-TEX Cardiovascular Patch — W. L. GORE & ASSOCIATES, INC · Class II
DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
ReTAP(TM) Cardiovascular Patch — SOLINAS MEDICAL INC. · Class II
Bard® DeBakey® Double Velour Knitted Polyester Fabric — Bard Peripheral Vascular · Class II
Bard® PTFE Felt — Bard Peripheral Vascular · 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: Teleflex Incorporated

Sources (1)

FDA UDI 7acd3386-7c71-4c78-9196-b77370cc474a 37 fields · synced Jun 6, 2026