AccessGUDID - DEVICE: Imperial Stainless Steel Revolving Stool (07540162040344)

GUDID

Device Identifier (DI) Information

Brand Name: Imperial Stainless Steel Revolving Stool
Version or Model: OR-36230
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OR-36230
Company Name: Imperial Surgical Ltd

Primary DI Number: 07540162040344
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 245253575 *Terms of Use

Device Description: Revolving Stool - as above but adj. 25 in to 32 in

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":	Yes
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?
32307	Operating room stool	A seat, usually padded and height-adjustable, intended to be occupied by operating room (OR) staff during surgical procedures as an alternative to standing; it does not include support for the back or arms. It is intended to be used in ORs or cleanrooms and is therefore constructed so that it is easy to clean to help minimize risk of contamination.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZM	Stool, Operating-Room

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: 886830a7-fef5-41af-a8c3-a425a83b2039
Public Version Date: August 20, 2024
Public Version Number: 2
DI Record Publish Date: January 13, 2021