AccessGUDID - DEVICE: WECK (34026704624820)

GUDID

Device Identifier (DI) Information

Brand Name: WECK
Version or Model: IPN028173
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 004200
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 34026704624820
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 14026704410283

Device Description: HORIZON TI LG 6 Clips/Cart

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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":	Yes
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?
35649	Ligation clip, metallic	A metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; 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 [?]
K982313	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
Length: 12.38 Millimeter
Height: 10.07 Millimeter
Device Size Text, specify: Horizon Large Ligating Clips, Single Pack, Titanium

Device Record Status

Public Device Record Key: 8cd3fdc2-7ccd-44e0-9a65-402d142105f6
Public Version Date: May 16, 2022
Public Version Number: 8
DI Record Publish Date: September 27, 2018