DEVICE: Brace Direct (00860011821847)

Device Identifier (DI) Information

Brace Direct
UCTY194-2
In Commercial Distribution

BRACE ALIGN LLC
00860011821847
GS1

1
108094498 *Terms of Use
Refurbished Brace Direct Cryotherapy Machine – Advanced Cold Therapy for Faster Recovery Experience the power of cold therapy with our refurbished Brace Direct Cryotherapy Machine. Expertly restored for peak performance, it helps relieve post-surgical pain, arthritis, muscle spasms, and sports injuries. Compact, quiet, and easy to use—your go-to for faster recovery and lasting relief.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
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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?
62442 Circulating-fluid localized thermal therapy system
An assembly of devices intended to be used to pump heated and/or cooled fluid (e.g., water) through externally applied packs for localized hot and/or cold therapy to help treat a variety of adverse conditions resulting from musculoskeletal injury (e.g., pain, swelling, inflammation). It includes one or more hot and/or cold therapy packs (e.g., anatomically specific wraps), and a mains electricity (AC-powered) fluid pump and heating/cooling unit with controls/display; the device is not intended for wrap inflation. It is intended for use in both professional and home settings.
Active false
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FDA Product Code

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Product Code Product Code Name
ILO Pack, Hot Or Cold, Water Circulating
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FDA Premarket Submission

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

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

1d6e12d8-284c-45cf-82c8-ffb5b801883e
March 20, 2025
1
March 12, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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Yes
No
None
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Production Identifier(s) in UDI

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Yes
Yes
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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