AccessGUDID - DEVICE: WECK (34026704623496)

GUDID

Device Identifier (DI) Information

Brand Name: WECK
Version or Model: IPN028267
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 544123
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 34026704623496
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 24026704600964

Device Description: HEM-O-LOK OPEN REMOVER MEDIUM/MEDIUM-LARGE/LARGE 11"

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	No
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?
10895	Surgical clip remover, reusable	A scissors- or tweezers-like surgical instrument with two blades joined at their proximal end or midpoint intended to be used to for grasping, opening, and removing a tissue clip. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDO	Applier, surgical, clip

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 10.5 Inch

Device Record Status

Public Device Record Key: 2112f0b5-ff81-40a4-83e4-aa9764559afc
Public Version Date: January 20, 2021
Public Version Number: 6
DI Record Publish Date: October 02, 2017