AccessGUDID - DEVICE: TASKA Lamination Collar Kit (6-band), 50mm, Sand (09421037390406)

GUDID

Device Identifier (DI) Information

Brand Name: TASKA Lamination Collar Kit (6-band), 50mm, Sand
Version or Model: TASKA-13AC01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TASKA PROSTHETICS LIMITED

Primary DI Number: 09421037390406
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 594832527 *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?
41091	Myoelectric wrist prosthesis	A powered artificial substitute for a missing wrist used as part of an upper-limb external prosthetic system and designed to restore some of the function of the joint. The device moves as the result of external motor power applied directly or via a connection with another functional limb component. Surface electrodes embedded in the device make contact with the skin and amplify muscle action potentials from voluntary contracting muscle in the residual limb/trunk, which turns on the motor to provide a function.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISZ	Unit, Wrist, External Limb Component, Mechanical

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: 6428acba-6905-4258-902b-e63cfd6a0c9c
Public Version Date: August 05, 2025
Public Version Number: 1
DI Record Publish Date: July 28, 2025