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M-Brace Air

FDA UDI

Class I (US FDA UDI)

by Indaco Srl

Identity

Trade Name
M-Brace Air FDA UDI
Generic Name
Wrist/hand/metacarpophalangeal joint extension orthosis FDA UDI
Device Name
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. FDA UDI
Model / Reference
137 R FDA UDI
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. FDA UDI

Identifiers

Catalog Number
137 FDA UDI
Primary DI / UDI-DI
05391512282066 FDA UDI
FDA Product Code
ILH FDA UDI
GMDN Term
Wrist/hand/metacarpophalangeal joint extension orthosis FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3475 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Wrist/hand/metacarpophalangeal joint extension orthosis

M-Brace Air by Indaco Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wrist/hand/metacarpophalangeal joint extension orthosis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Indaco Srl

Sources (1)

  • FDA UDI 92fd065d-ead1-438f-9fbd-4838ca3e3f25 35 fields · synced May 30, 2026