AccessGUDID - DEVICE: WECK (34026704631811)

GUDID

Device Identifier (DI) Information

Brand Name: WECK
Version or Model: IPN028499
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 658505
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 34026704631811
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 34026704630401

Device Description: RANEY CLIPS DISPOSABLE 10/pouch

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?
46953	Scalp wound clip	A small, nonimplantable device in the form of a U-shaped clip that is fired from a dedicated scalp-clip applier (clip gun) or manually applied using dedicated scalp clip forceps, to approximate the margins of a scalp wound/incision associated with a surgical intervention on the cranium/scalp. It is made of metal or plastic materials and is typically applied in rows; it is intended to remain in place until the incision has healed. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HBO	CLIP, SCALP

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: 0.625 Inch

Device Record Status

Public Device Record Key: 76e42901-388b-442f-a054-f817c15d1365
Public Version Date: January 11, 2024
Public Version Number: 4
DI Record Publish Date: April 16, 2019