DEVICE: iGrow Hair Growth System (00861134000102)

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Device Identifier (DI) Information

iGrow Hair Growth System
PE104IG00

APIRA SCIENCE, INC.
00861134000102
GS1
1
iGrow Hair Growth System, Standard Single Unit
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
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No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Hair growth laser device An electronic, portable, head-worn or hand-operated device intended to be operated by a layperson affected by scalp hair loss (i.e., receding hairline/baldness due to androgenic alopecia) to stimulate hair growth on the scalp through the application of scheduled low-level laser therapy (LLLT). The device uses individual laser diodes to direct laser light at the scalp. It may include features (e.g., a comb) to separate the user's hair to allow for improved penetration of the laser light. It is normally available [non-prescription] over-the-counter (OTC) for use in the home.
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FDA Product Code

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Product Code Product Code Name
OAP Laser, Comb, Hair
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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 Status

In Commercial Distribution
September 26, 2016

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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
20861134000102 2 00861134000102 In Commercial Distribution 2-pack
10861134000102 6 00861134000102 In Commercial Distribution Master Carton
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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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Yes
No
No
No
No CLOSE

Customer Contact

[?]
(561) 465-7005
mmartinsen@apirascience.com
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