AccessGUDID - DEVICE: FAUTEUIL HIPPOCAMPE L ROSE/ WHEELCHAIR HIPPOCAMPE L PINK (03664560000015)

GUDID

Device Identifier (DI) Information

Brand Name: FAUTEUIL HIPPOCAMPE L ROSE/ WHEELCHAIR HIPPOCAMPE L PINK
Version or Model: 0001-TL-02-RO
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SARL VIPAMAT

Primary DI Number: 03664560000015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 264013397 *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?
46137	Multi-terrain sports wheelchair, attendant/occupant-driven	A wheeled personal mobility device incorporating a seat-support system for a person with a walking disability that is manually propelled by the user while seated in the device, and alternatively by an attendant, for multi-/all-terrain sports use (e.g., at the beach, in the forest or mountains). The occupant moves the device by rotating a pair of wheels; an attendant moves the device by pushing or pulling handles or a bar on the device. This device is designed for unlimited off-road sports use on sand, rocky terrain, grass, snow, wet ground, and/or in water.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
IQC	Wheelchair, Special Grade

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051709	000

Device Exempt from Premarket Submission: No 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: 11a4a69c-e018-4da7-8ae9-b7c07d8d9f69
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: May 26, 2017