DEVICE: BIOS Living (00057475700324)

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Device Record History
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Device Identifier (DI) Information
BIOS Living
70032
In Commercial Distribution

Thermor Ltd
00057475700324
GS1

1
246883458 *Terms of Use
Diabetic Socks, White, Large
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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?
58831 Antimicrobial sock
A tubular, fabric device intended to be worn on the feet of a patient to help maintain foot health and reduce the growth of fungi and bacteria through inclusion of an antimicrobial agent [e.g., pure cotton yarn containing silver (Ag) nanoparticles]. It is typically indicated for a patient who suffers from athlete’s foot, diabetic foot, neurological sensory disorders (e.g., unable to feel micro traumas, touch, or temperature), and impaired blood circulation; it is generally intended to reduce the risk of primary and secondary infection. The device is normally available for daily use in the home or healthcare facility. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FQL Stocking, Medical Support (For General Medical Purposes)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
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

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Size Type Text
No Device Sizes
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Device Record Status
961ef1a1-44ed-4192-ba7a-aa60df95508b
November 15, 2023
1
November 07, 2023
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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
20057475700328 3 00057475700324 In Commercial Distribution Case
10057475700321 8 20057475700328 In Commercial Distribution Case
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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)

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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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