DEVICE: TM "Rehabilitimed" RP-6K-M1 UNIp-2 Comfort (04823097723586)

Device Identifier (DI) Information

TM "Rehabilitimed" RP-6K-M1 UNIp-2 Comfort
RP-6K-M1 UNIp-2 Comfort
In Commercial Distribution
RP-6K-M1 UNIp-2 Comfort
REABILITIMED TOV
04823097723586
GS1

1
364875768 *Terms of Use
The turquoise blue shoulder brace provides a medium degree of fixation of the elbow joint and shoulder girdle. The arm sleeve is easily unfastened with a textile fastener and provides free access. Equipped with a belt girdling the chest with the arm pressed to the body to fix and prevent the arm from being pulled away.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
No
No
No
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?
41053 Elbow orthosis
A prefabricated (non-customized) externally applied and wearable orthopaedic appliance designed to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
IOY Support, Arm
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Chest circumference with arm pressed (inch): 23,5-27
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Device Record Status

f25e756b-25f9-4f0d-9e48-1eef8cfecaa0
May 26, 2025
1
May 17, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
835 5030395
Krut.Lora@gmail.com
+380965139983
shenyalipinskiy@gmail.com
+380937042825
reabilitimed@ukr.net
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