AccessGUDID - DEVICE: Turtlebrace (10628634832162)

GUDID

Device Identifier (DI) Information

Brand Name: Turtlebrace
Version or Model: Elbow Baby
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TBBCo-01, TBBCo-02, TBBCo-03, TBBCo-04
Company Name: 9321-8758 Québec Inc

Primary DI Number: 10628634832162
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 203875315 *Terms of Use

Device Description: The brace 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 brace can be molded directly to the patient to immobilize an elbow 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 small (01), medium (02), large (03), or extra large (04) for Baby (BB)

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: BB S for baby small
Device Size Text, specify: BB M for baby medium
Device Size Text, specify: BB L for baby large
Device Size Text, specify: BB XL for baby extra large

Device Record Status

Public Device Record Key: 707d9dd6-ae9e-468b-b29b-b7b3461dd34d
Public Version Date: January 24, 2023
Public Version Number: 1
DI Record Publish Date: January 16, 2023