Disposable Kit FP-47842

GUDID 00850470007333

RESTORATION ROBOTICS, INC.

Hair extraction punch
Primary Device ID00850470007333
NIH Device Record Keye1c765b5-37bf-4ab9-943c-ab1cb58a4217
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Kit
Version Model Number19G 4 Prong 4mm Punch, Sterile
Catalog NumberFP-47842
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
GS100850470007333 [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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