AccessGUDID - DEVICE: Imperial St/St Mayo St.4cast.sled base c/w Tray (07540162041068)

GUDID

Device Identifier (DI) Information

Brand Name: Imperial St/St Mayo St.4cast.sled base c/w Tray
Version or Model: OR-36570
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OR-36570
Company Name: Imperial Surgical Ltd

Primary DI Number: 07540162041068
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 245253575 *Terms of Use

Device Description: St/St Mayo St.4cast.sled base c/w Tray

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?
61454	Surgical tray stand	A mobile, freestanding device intended to be used during a surgical procedure onto/into which a surgical tray (e.g., surgical sponge-counting tray) can be placed. It consists of a metal vertical upright on a wheeled base with a top surface that may allow for integration of dedicated surgical trays. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FWZ	Operating Room Accessories Table Tray

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: 60392283-2294-4830-943c-93046751d2ea
Public Version Date: August 07, 2023
Public Version Number: 1
DI Record Publish Date: July 28, 2023