AccessGUDID - DEVICE: M-Brace Air (05391512284350)

GUDID

Device Identifier (DI) Information

Brand Name: M-Brace Air
Version or Model: 66T
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 66T
Company Name: INDACO SRL

Primary DI Number: 05391512284350
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338470646 *Terms of Use

Device Description: Telescopic Post-Operative Knee Brace (#66T) This medical device is a Post-Op Knee brace with articulated telescopic bars in light aluminium alloy, padded by soft MTP and sponge fabric in contact with skin to reduce sweating. It has separate bands in order to ensure greater breathability of the leg and valves for belts specially designed to reduce the pressure of the bands. It also has adjustable strap closures that insures the orthosis is tightly secured to the limb. The knee brace has a Range of Motion Joint, adjustment of flexion and extension at 10° (flexion 0° / 120°; extension 0° / 90°) and an option to block joint every 10°. It contains condylar protective detachable pads. Its shape provides an excellent anatomic stabilization of the limb and comfortable to wear and use. One size fits all. L1832 or L1833 approved. INDICATIONS Post-operative knee ligament reconstruction treatment, complete prosthesis, femoral or tibia fractures at the knee, valgus and varus osteotomy. Recommended to treat post-traumatic knee strain requiring semi-flexion immobilization.

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:	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?
41065	Knee support orthosis	A stand-alone prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee; it may incorporate hinges for improved support. It is not a component of a larger device assembly. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITQ	Joint, Knee, External 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
No Device Sizes

Device Record Status

Public Device Record Key: b5f7b354-182b-4ad4-bd9d-bae629db6ba2
Public Version Date: February 21, 2024
Public Version Number: 1
DI Record Publish Date: February 13, 2024