DEVICE: Braun Silk.expert Pro 5 (00069055886366)

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Device Record History
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Device Identifier (DI) Information
Braun Silk.expert Pro 5
PL5014
Not in Commercial Distribution

PROCTER & GAMBLE MANUFACTURING COMPANY, THE
00069055886366
GS1
September 08, 2023
1
004238200 *Terms of Use
Light Based Over-The-Counter Hair Removal
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
Yes
Yes
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?
65776 Home-use intense pulsed light hair removal unit
A hand-held, electrically-powered device designed to be used in the home to produce strong, controlled flashes of filtered light in the wavelength range of 400 - 1200nm [intense pulsed light (IPL)] for self-removal of unwanted hair.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GEX Powered Laser Surgical Instrument
OHT Light based over-the-counter hair removal
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between -25 and 70 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
4c00c71b-a3e0-486b-8504-d2946496668e
September 25, 2024
3
September 08, 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
10069055886363 2 00069055886366 2023-09-08 Not in Commercial Distribution Box
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Secondary DI

[?]
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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)272-8611
xx@xx.xx
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