AccessGUDID - DEVICE: Bari + Max Bariatric Steel Crutches, Adult, 1000 lb. Weight Capacity, 1 Pair (00840117325937)

GUDID

Device Identifier (DI) Information

Brand Name: Bari + Max Bariatric Steel Crutches, Adult, 1000 lb. Weight Capacity, 1 Pair
Version or Model: 10106
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dynarex Corporation

Primary DI Number: 00840117325937
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008124539 *Terms of Use

Device Description: No description.

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:	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?
31115	Axillary crutch	A staff-like mobility aid used to assist a person with a disability to support their weight while walking. The device has one leg, a padded hand support at the level of the user's wrist, and an under-arm (the armpit or axilla) padded platform. The pads are typically made of non-slip material (e.g., rubber, glycerin gel, sheepskin). The device may be adjustable in length and is typically made of wood or metal [e.g., aluminium (Al), titanium (Ti)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IPR	Crutch

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: 1b373f70-34bc-455a-a389-598bdeb3f856
Public Version Date: October 09, 2024
Public Version Number: 2
DI Record Publish Date: January 11, 2023