DEVICE: CTC-7 (08809315679572)

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Device Record History
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Device Identifier (DI) Information
CTC-7
CTCAFDA
Not in Commercial Distribution

DAESUNG MAREF CO.,LTD.
08809315679572
GS1
December 07, 2021
1
688817949 *Terms of Use
One person use ankle air pad 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
afc7dd70-de87-426c-9315-0d0df3d5f5ad
December 18, 2023
4
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
18809315679579 5 08809315679572 2021-12-07 Not in Commercial Distribution Box
28809315679576 10 08809315679572 2021-12-07 Not in Commercial Distribution Box
38809315679573 30 08809315679572 2021-12-07 Not 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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