AccessGUDID - DEVICE: M-Brace Air (05391512282066)

GUDID

Device Identifier (DI) Information

Brand Name: M-Brace Air
Version or Model: 137 R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 137
Company Name: INDACO SRL

Primary DI Number: 05391512282066
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338470646 *Terms of Use

Device Description: The 137 is an accessory only, must be used with product 134 or 136 wrist splints only. The main features of the M-Brace Thumb splint are: -an advanced fabric ensuring a very confortable touch while allowing the skin to breathe; -right and left models available; -a structure which can be totally opened so that wearing the splint is easy and painless; -moldable support. RIZOFIX, the patented thumb block system immobilizes the thumb from the inner side, leaving the opposite side free. INDICATIONS: Traumatic pathologies: distortions, carpal-metacarpal fractures, tendonitis. Degenerative pathologies: root arthrosis, carpal tunnel syndrome, arthrosis. Rehab phase: provides post-trauma and post-op tendon muscle relief.

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):	Yes
Kit:	No
Combination Product:	Yes
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?
41461	Wrist/hand/metacarpophalangeal joint extension orthosis	An externally applied orthopaedic appliance or apparatus designed to assist in the extension of the wrist, hand, and metacarpophalangeal joints (MP joints or knuckles). The device has an outrigger (a projecting support) to assist in the extension of the thumb. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILH	Splint, Hand, And Components

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: 92fd065d-ead1-438f-9fbd-4838ca3e3f25
Public Version Date: March 01, 2024
Public Version Number: 1
DI Record Publish Date: February 22, 2024