AccessGUDID - DEVICE: DRIVE (00822383000770)

GUDID

Device Identifier (DI) Information

Brand Name: DRIVE
Version or Model: RTL10336RG
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Drive Devilbiss Healthcare

Primary DI Number: 00822383000770
Issuing Agency: GS1
Commercial Distribution End Date: April 24, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 867673159 *Terms of Use
Previous DI: 00822384002568

Device Description: Canes & Crutches T-Handle Product Description Cane T-Handle Erg, Rose Golds 1/ea,6/cv

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):	Yes
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
IPS	CANE

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: 84ed6f1f-cf14-4aea-bcfe-bde87012a96b
Public Version Date: April 24, 2020
Public Version Number: 2
DI Record Publish Date: February 08, 2020