AccessGUDID - DEVICE: EMYS (08055774710909)

GUDID

Device Identifier (DI) Information

Brand Name: EMYS
Version or Model: AH/PGV-MB
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TARTA DESIGN SRL

Primary DI Number: 08055774710909
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 430766724 *Terms of Use

Device Description: Emys- High adjustable clamp for folding wheelchair with rigidizer bar - Size M BLACK COLOUR

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):	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?
64619	Wheelchair back rest positioner	A bracket-like device intended to be attached to the back canes of a wheelchair to accept the wheelchair back rest (not included) and allow for the adjustment of the back rest position (e.g., angle, depth, height). It is typically in the form of a clamp with hooks of adjustable position/orientation; pins intended to secure positioning may also be included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IMS	Support, Head And Trunk, Wheelchair

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: dd7f6753-9d0c-4a03-bb6d-aef9162c0f85
Public Version Date: May 10, 2021
Public Version Number: 1
DI Record Publish Date: May 01, 2021