AccessGUDID - DEVICE: 50510 Single Dispenser Rack Two Sets of Hooks In Front Wall & IV Pole (00787551012347)

GUDID

Device Identifier (DI) Information

Brand Name: 50510 Single Dispenser Rack Two Sets of Hooks In Front Wall & IV Pole
Version or Model: 50510
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 50510
Company Name: XODUS MEDICAL, INC.

Primary DI Number: 00787551012347
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 868042664 *Terms of Use

Device Description: 50510 Single Dispenser Rack Two Sets of Hooks In Front Wall & IV Pole

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?
64548	Surgical sponge-counting bag	A device in the form of a bag intended to be used in the operating room (OR) to store and maintain the count of surgical sponges/swabs during a surgical procedure to prevent these items from being inadvertently left in a patient. It is a bag with individual pockets/sections and is typically hung on an associated rack (not included); it may be weighed following sponge/swab collection to calculate blood loss. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQA	SCALE, SURGICAL SPONGE

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: 212905ce-4eca-49bf-927a-acf48e529fab
Public Version Date: December 16, 2022
Public Version Number: 1
DI Record Publish Date: December 08, 2022