Weck

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: WECK FDA UDI
Generic Name: Laparoscopic access cannula, single-use FDA UDI
Device Name: WECKVISTA PORT 5 MILLIMETER X 70 MILLIMETER RIDGED FDA UDI
Model / Reference: IPN914272 FDA UDI
Description: WECKVISTA PORT 5 MILLIMETER X 70 MILLIMETER RIDGED FDA UDI

Identifiers

Catalog Number: 43507R FDA UDI
Primary DI / UDI-DI: 14026704645265 FDA UDI
510(k) Number: K010007 FDA UDI
FDA Product Code: GCJ FDA UDI
GMDN Term: Laparoscopic access cannula, single-use 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

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

Dimensions & Sizes

Size: Width — 5 Millimeter FDA UDI
Length — 70 Millimeter FDA UDI

Category: Laparoscopic access cannula, single-use

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

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Also classified as Laparoscopic access cannula, single-use.

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Busse Hospital Disposables — ROBERT BUSSE & CO., INC. · Class II

Cleared under the same submission

K010007 also covers:

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 835cf5f3-a0bc-4a6a-ae5f-7b4ef7bc5633 37 fields · synced May 30, 2026