AccessGUDID - DEVICE: DARCO® TAS™ (Toe Alignment Splint) (04251853900153)

GUDID

Device Identifier (DI) Information

Brand Name: DARCO® TAS™ (Toe Alignment Splint)
Version or Model: TAS-22
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TAS-22
Company Name: Darco (Europe) GmbH

Primary DI Number: 04251853900153
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 343551081 *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:	Yes
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?
65660	Finger/toe buddy strap	A flexible prefabricated (non-customized) wearable device designed to be wrapped around an injured/diseased finger or toe and the adjacent digit to function as a splint-like strap for immobilization of the injured/diseased digit to facilitate healing and/or pain relief. It is made of soft materials and has self-retaining fastening. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NOC	Splint, extremity, non-inflatable, external, non-sterile

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: 66029e4c-ccfb-4da6-8c63-2793b625a23d
Public Version Date: June 30, 2025
Public Version Number: 3
DI Record Publish Date: February 08, 2023