AccessGUDID - DEVICE: Wenzellite (00822383901190)

GUDID

Device Identifier (DI) Information

Brand Name: Wenzellite
Version or Model: FC100-2GP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Drive Devilbiss Healthcare

Primary DI Number: 00822383901190
Issuing Agency: GS1
Commercial Distribution End Date: August 19, 2024
Device Count: 6
Labeler D-U-N-S® Number*: 867673159 *Terms of Use

Device Description: Wenzelite Pediatric Crutches Product Description Forearm Crutch, Small, Purple, Pair

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
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: 2f427283-44ff-4c0e-9c3f-0188f68e42f1
Public Version Date: August 20, 2024
Public Version Number: 2
DI Record Publish Date: February 01, 2020