AccessGUDID - DEVICE: TARTA KID PRO (08055774711050)

GUDID

Device Identifier (DI) Information

Brand Name: TARTA KID PRO
Version or Model: KPINT01F-AS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TARTA DESIGN SRL

Primary DI Number: 08055774711050
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 430766724 *Terms of Use

Device Description: UNIVERSAL INTERFACE FOR RIGID BASE SIZE 01

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
KNO	Accessories, 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: aae27dd4-6052-4a53-8d39-720cc144a212
Public Version Date: May 10, 2021
Public Version Number: 1
DI Record Publish Date: May 01, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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