DEVICE: BIOS Living (00057475211301)

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Device Record History
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Device Identifier (DI) Information
BIOS Living
LK130
In Commercial Distribution

Thermor Ltd
00057475211301
GS1

1
246883458 *Terms of Use
Lice Comb Kit
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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?
17552 Lice comb, manual
A hand-held manual device with specially-designed teeth (tines) spaced with precision and intended to be systematically drawn through the hair, typically following the contour of the scalp, to expose and remove human head lice (Pediculus humanus capitis) and their eggs (nits) from the hair and scalp of an infested person. It is normally available non-prescription and over-the-counter (OTC). This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LJL Detectors And Removers, Lice, (Including Combs)
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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

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Size Type Text
No Device Sizes
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Device Record Status
0cec0daf-425f-458a-a97d-941e4e880bff
September 26, 2023
1
September 18, 2023
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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
10057475211308 12 00057475211301 In Commercial Distribution Case
20057475211305 8 10057475211308 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)

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No
No
None
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Production Identifier(s) in UDI

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No
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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