AccessGUDID - DEVICE: WECK (14026704631749)

GUDID

Device Identifier (DI) Information

Brand Name: WECK
Version or Model: IPN028496
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 382800
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704631749
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 04026704599745

Device Description: DURAHOOK 1/4 HOOK 10 PACKAGES PER BOX /6 HOOKS PER PACKAGE

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?
47991	Self-retaining surgical retractor, single-use	A sterile, hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAO	INSTRUMENT, SURGICAL, NON-POWERED

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
Width: 0.25 Inch
Length: 4.5 Inch

Device Record Status

Public Device Record Key: e98970b4-32f8-48e8-bb29-b60d1c1468b8
Public Version Date: January 18, 2021
Public Version Number: 3
DI Record Publish Date: August 24, 2018