AccessGUDID - DEVICE: WECK (14026704725745)

GUDID

Device Identifier (DI) Information

Brand Name: WECK
Version or Model: IPN920971
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 544250
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704725745
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 24026704695953

Device Description: HEMOLOK XL 6 Clips/Cart

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FZP	Clip, implantable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133202	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Hemolok Xtra-LargeLigating Clips, Polymer
Height: 13.84 Millimeter

Device Record Status

Public Device Record Key: f1fab5ac-8c3e-4aee-b8a1-f35359193e4c
Public Version Date: December 14, 2023
Public Version Number: 1
DI Record Publish Date: December 06, 2023