WECK

Basic Information

• Brand Name: WECK
• Primary DI: 14026704601100
• Version / Model: IPN009035
• Catalog Number: 544205
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2015-10-16
• Public Version: 5
• Public Version Date: 2022-08-17
• Public Version Status: Update
• Public Device Record Key: 2c278dac-3451-4a6d-bb25-a6ae8b163030

Device Description

HEMOLOK SMX NS 6 Clips/Cart

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FZP	CLIP, IMPLANTABLE	General, Plastic Surgery	878.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56711	Ligation clip, synthetic polymer, non-bioabsorbable	A non-metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel or a tissue bundle for permanent occlusion. It is typically made of plastic materials [e.g., polyoxymethylene (POM), commonly known as Delrin] and may be designed with a self-locking catch. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries, but is usually not intended for fallopian tube occlusion. Its non-metallic design makes it more compatible with radiological imaging than metallic clips. A dedicated, disposable clip applier may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	24026704601107	GS1	Box	20	Not in Commercial Distribution	2022-08-11
Primary	14026704601100	GS1
Unit of Use	04026704601103	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K133202	000

Device Sizes

Type	Value	Unit	Text
Height	2.64	Millimeter
Device Size Text, specify			Hemolok Clips, NOT FOR SALE, NOT FOR HUMAN USE