WECK

Basic Information

• Brand Name: WECK
• Primary DI: 14026704553126
• Version / Model: IPN010797
• Catalog Number: AE05ML
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-30
• Public Version: 4
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 35a9bd19-fd47-4ee0-b881-5d166c013b3f

Device Description

AUTOMATIC END0SCOPIC 5 MEDIUM LARGE

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

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
58040	Laparoscopic clip applier	A sterile, rigid device designed to perform through a compatible laparoscopic instrument (e.g., a laparoscopic sleeve) for the application of an implantable clip(s), to achieve ligation/occlusion during transection or for radiographic marking. It typically consists of an insertion sheath, a mechanism at the distal end for applying the clips, an integral cassette containing the surgical or ligation clips, and a control handle at the proximal end for firing the clips into the target tissue. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	24026704553123	GS1	Box	3	In Commercial Distribution
Package	04026704553129	GS1	Box	1	In Commercial Distribution
Primary	14026704553126	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K152081	000

Device Sizes

Type	Value	Unit	Text
Length	35	Centimeter