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: PLED SOFT LG 3/8"X3/16"X1/16" X100NS FDA UDI
Model / Reference: IPN016085 FDA UDI
Description: PLED SOFT LG 3/8"X3/16"X1/16" X100NS FDA UDI

Identifiers

Catalog Number: L-99 FDA UDI
Primary DI / UDI-DI: 24026704423860 FDA UDI
FDA Product Code: DXZ FDA UDI
GMDN Term: Cardiovascular patch, synthetic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.3470 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Length — 90 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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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 e0c0cff3-1406-4396-ac72-039887fa6c95 36 fields · synced May 30, 2026