DEVICE: TM "Rehabilitimed" TUTOR-N Sp Comfort (04823097720233)
Device Identifier (DI) Information
TM "Rehabilitimed" TUTOR-N Sp Comfort
TUTOR-N Sp Comfort
In Commercial Distribution
TUTOR-N Sp Comfort
REABILITIMED TOV
TUTOR-N Sp Comfort
In Commercial Distribution
TUTOR-N Sp Comfort
REABILITIMED TOV
It is a knee joint brace, graphite in color. It is made of modern multilayer material (special velor triple-layered fabric (glued in a special way with polyurethane foam) with cotton terry cloth) and is reinforced with 4 removable rigid metal tires located on the back and side surfaces of the lower limb. Equipped with a system of six belts with textile fasteners.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
Yes | |
No | |
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No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ITM | Cage, Knee |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Child's age: up to 1 year |
Device Size Text, specify: Tutor height (cm): 24 |
Device Record Status
ce2bd629-c627-41d2-a200-62670996f1aa
May 12, 2025
1
May 04, 2025
May 12, 2025
1
May 04, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
835 5030395
Krut.Lora@gmail.com +380965139983
shenyalipinskiy@gmail.com +380937042825
reabilitimed@ukr.net
Krut.Lora@gmail.com +380965139983
shenyalipinskiy@gmail.com +380937042825
reabilitimed@ukr.net