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Weck

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 544995T

by Teleflex Incorporated

Identity

Trade Name
HEMOLOK TAKEAPART LARGE 10 MILIMETER ENDOSCOPIC APPLIER EUDAMED
WECK FDA UDI
Generic Name
Open-surgery ligation clip applier FDA UDI
Device Name
Weck® Hem-o-lok® Take Apart Endoscopic Ligating Cl EUDAMED
HEMOLOK TAKEAPART LARGE 10 MILIMETER ENDOSCOPIC APPLIER FDA UDI
Model / Reference
544995T EUDAMED
IPN921711 FDA UDI
Description
HEMOLOK TAKEAPART LARGE 10 MILIMETER ENDOSCOPIC APPLIER FDA UDI

Identifiers

Catalog Number
544995T FDA UDI
Primary DI / UDI-DI
14026704727589 EUDAMEDFDA UDI
Basic UDI-DI
08019020000000000000011JV EUDAMED
Direct Marketing DI
44026704727580 EUDAMED
FDA Product Code
GDO FDA UDI
EMDN Code
L020802 MULTIPLE APPLICATORS OF CLIPS FOR VIDEO SURGERY, REUSABLE EUDAMED
GMDN Term
Open-surgery ligation clip applier FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
878.4800 FDA UDI
Market of Registration
Ireland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Open-surgery ligation clip applier

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

Similar devices

Also classified as Open-surgery ligation clip applier.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Sources (2)

  • FDA UDI 37e0b9a4-53da-43b3-b1c6-1693b86cbffe 35 fields · synced Jul 15, 2026
  • EUDAMED 42c47e08-e093-4039-a9c7-19cf45e14a24 61 fields · synced Jul 15, 2026