AccessGUDID - DEVICE: WECK (14026704736314)

GUDID

Device Identifier (DI) Information

Brand Name: WECK
Version or Model: IPN917215
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 525980
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704736314
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 14026704631763

Device Description: WECKSTAT STAPLE EXTRACTOR 12/BOX

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:	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?
47192	Skin staple remover, single-use	A hand-held manual surgical instrument intended to be used to remove skin staples after the healing process has progressed sufficiently to permit the borders of the wound or incision to remain together without assistance. It is a tweezers-like device made of metallic or synthetic polymer materials with blades at the distal end activated by lever action designed for grasping, opening, and removing surgical staples. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QQS	Stapler, skin

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: 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: 5.6 Inch

Device Record Status

Public Device Record Key: ea2b9e8e-4415-4664-b22a-7659b334f4ce
Public Version Date: July 17, 2024
Public Version Number: 1
DI Record Publish Date: July 09, 2024