DEVICE: Hydrafacial MD Elite (00810007531311)

Device Identifier (DI) Information

Hydrafacial MD Elite
240V
In Commercial Distribution
70290-03-01
Hydrafacial LLC
00810007531311
GS1

1
364134791 *Terms of Use
220-240VAC, 50/60Hz, 8A
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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?
11177 Skin abrasion unit
A mains electricity (AC-powered) device used for the removal of the skin surface by abrasion (applied by some kind of rotating abrasive tool, e.g., a wire brush or emery disc). It may be used during plastic surgery and can be used for treatments such as the removal of scars, tattoos, pigmented nevi, fine wrinkles, or other irregularities of the skin. This GMDN code may reflect old technology.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GFE Brush, Dermabrasion, Powered
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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

2fc32fa1-d63e-4e8a-b200-2aa220d597e7
July 26, 2024
1
July 18, 2024
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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
No Package DIs found
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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

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
8006034996
regulatory@hydrafacial.com
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