Disposable Kit FP-47844

GUDID 00850470007326

RESTORATION ROBOTICS, INC.

Hair extraction punch
Primary Device ID00850470007326
NIH Device Record Keya0be7a5e-8c56-4378-a854-e032c50c4334
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Kit
Version Model Number18G 4 Prong 4mm Punch, Sterile
Catalog NumberFP-47844
Company DUNS627212587
Company NameRESTORATION ROBOTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850470007326 [Primary]

FDA Product Code

ONAComputer Assisted Hair Harvesting System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-08

On-Brand Devices [Disposable Kit]

0085047000733319G 4 Prong 4mm Punch, Sterile
0085047000732618G 4 Prong 4mm Punch, Sterile
00850470007227Non-Sterile Site Making
00850470007210Sterile Site Making
00850470007203Site Making
0085047000707419G Sterile
00850470007050Non-Sterile
0085047000704318G Sterile

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