Weck

FDA UDI

Class I (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: WECK FDA UDI
Generic Name: Self-retaining surgical retractor, single-use FDA UDI
Device Name: DURAHOOK 1/4 HOOK 10 PACKAGES PER BOX /6 HOOKS PER PACKAGE FDA UDI
Model / Reference: IPN028496 FDA UDI
Description: DURAHOOK 1/4 HOOK 10 PACKAGES PER BOX /6 HOOKS PER PACKAGE FDA UDI

Identifiers

Catalog Number: 382800 FDA UDI
Primary DI / UDI-DI: 14026704631749 FDA UDI
FDA Product Code: HAO FDA UDI
GMDN Term: Self-retaining surgical retractor, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 882.4535 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Width — 0.25 Inch FDA UDI
Length — 4.5 Inch FDA UDI

Category: Self-retaining surgical retractor, single-use

Weck by Teleflex Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Endo Retract — Covidien LP · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Teleflex Incorporated

Sources (1)

FDA UDI e98970b4-32f8-48e8-bb29-b60d1c1468b8 36 fields · synced May 31, 2026