AccessGUDID - DEVICE: Turtlebrace (80628634832123)

GUDID

Device Identifier (DI) Information

Brand Name: Turtlebrace
Version or Model: Universal Thumb Attachement
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EPUA
Company Name: 9321-8758 Québec Inc

Primary DI Number: 80628634832123
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 203875315 *Terms of Use

Device Description: This is a thumb add-on for the Turtlebrace wrist brace. It is composed of a low-temperature thermoplastic fused between a layer of 3D stretchable knitted fabric and a layer of 3D stretchable knitted velcro receptive fabric. The add-on is fused to the wrist brace and then it can be molded directly to the patient to immobilize a thumb, with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace. Size Universal

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):	Yes
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?
66055	Custom-made upper-limb orthosis	An externally-applied wearable appliance constructed with specific characteristics (e.g., size, shape, material), as prescribed by a healthcare provider for a specified patient (custom-made), intended to support and correct deformities of the arm and/or hand. It may be one of numerous different designs and is typically made of synthetic and textile materials. This is a single-patient reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IQI	Orthosis, Limb Brace

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
Device Size Text, specify: Unvsl for Universal

Device Record Status

Public Device Record Key: d3f5bd02-b406-4864-a028-78d2ce344cca
Public Version Date: January 24, 2023
Public Version Number: 1
DI Record Publish Date: January 16, 2023