AccessGUDID - DEVICE: Graft Cleaning Bowl (00810072350954)

GUDID

Device Identifier (DI) Information

Brand Name: Graft Cleaning Bowl
Version or Model: Graft Cleaning Bowl
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 630.000
Company Name: Cole Instruments Inc

Primary DI Number: 00810072350954
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078573265 *Terms of Use

Device Description: Graft cleaning bowl used in the cleaning of follicles removed from the donor area before they are entered into the recipient area.

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):	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?
42893	General-purpose bowl, reusable	A portable bowl or basin designed to be used for a variety of medical purposes such as containing fluids, carrying or holding instruments prior to or during a procedure, and collecting body waste or other matter. The design and shape can vary including round, oblong, deep or quite shallow. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IDX	Sieves, Tissue

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
No Device Sizes

Device Record Status

Public Device Record Key: 27d6ac9d-0d59-4eb4-ad4b-955e2b16501f
Public Version Date: July 20, 2023
Public Version Number: 2
DI Record Publish Date: December 14, 2021