AccessGUDID - DEVICE: Graft Washing Station (00810072351203)

GUDID

Device Identifier (DI) Information

Brand Name: Graft Washing Station
Version or Model: Graft Washing Station
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 631.000
Company Name: Cole Instruments Inc

Primary DI Number: 00810072351203
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078573265 *Terms of Use

Device Description: This station pumps fluid (usually normal saline) over grafts that have been dissected to remove skin tissue from the follicles prior to their preservation before they are inserted into the recipient area of the forehead after hair transplant.

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):	No
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?
16023	Mobile sink system	An assembly of devices designed for use by healthcare personnel, patients, or other persons for hand washing, and without installation to external water supplies and/or drainage. It typically consists of a structure made of plastics, metals, or a combination of these materials, and usually includes a fresh water tank, a waste water tank, tubing, and taps (faucets); it may also include a soap dispenser, a paper towel rack, and an electrically-powered water pump. A portable sink is used in field work, during emergencies, in mobile medical facilities and shelters, and for personal hygiene of persons with a disability that cannot move from a location.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c579981d-0220-4306-b3c9-7ef5c82808a0
Public Version Date: December 16, 2022
Public Version Number: 1
DI Record Publish Date: December 08, 2022