DEVICE: CTC-7 (08809315679602)

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Device Record History
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Device Identifier (DI) Information
CTC-7
CTCBFD0
In Commercial Distribution

DAESUNG MAREF CO.,LTD.
08809315679602
GS1

1
688817949 *Terms of Use
One person use waist wrap 1ea
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
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?
32965 Circulating-fluid localized thermal therapy system pack, reusable
A device intended to be applied to part of the body as part of a circulating-fluid localized thermal therapy system to provide localized heat and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It typically consists of a compact envelope that is heated and/or cooled with circulating fluid (e.g., water) from the system control unit. It is intended for use in both professional and home settings. This is a reusable device.
Active false
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FDA Product Code

[?]
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
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
No Device Sizes
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Device Record Status
5fe49dbd-f644-431a-b8b1-561f6ecebc40
December 18, 2023
3
June 15, 2021
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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
18809315679609 10 08809315679602 In Commercial Distribution Box
28809315679606 20 08809315679602 In Commercial Distribution Box
38809315679603 40 08809315679602 In Commercial Distribution Box
48809315679600 80 08809315679602 In Commercial Distribution Box
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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
No
Yes
Yes CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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