AccessGUDID - DEVICE: Barbell Loop Ostomy Device (00860002701325)

GUDID

Device Identifier (DI) Information

Brand Name: Barbell Loop Ostomy Device
Version or Model: BAR-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BAR-2
Company Name: TOOLS FOR SURGERY, LLC

Primary DI Number: 00860002701325
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 841842441 *Terms of Use

Device Description: Loop Ostomy Device, Small (2-inch rod).

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):	Yes
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?
31987	Colostomy rod	A device that is placed through a loop of colon brought out through the abdominal wall to temporarily keep it from sliping back through the surgical opening during the loop colostomy procedure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EZP	Rod, Colostomy

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: Yes
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
Length: 2 Inch

Device Record Status

Public Device Record Key: 61ff0329-dfe1-4ef3-927f-41d7997030f4
Public Version Date: July 25, 2023
Public Version Number: 1
DI Record Publish Date: July 17, 2023