Disposable Kits, 20G FP-101284

GUDID 00850470007319

RESTORATION ROBOTICS, INC.

Hair extraction punch
Primary Device ID00850470007319
NIH Device Record Key1abaf413-8e0b-40b8-8df0-9468000c7164
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Kits, 20G
Version Model Number4 prong 6mm punch
Catalog NumberFP-101284
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 Datefalse
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
GS100850470007319 [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 Date2017-01-31

On-Brand Devices [Disposable Kits, 20G]

008504700073194 prong 6mm punch
008504700072962 prong 6mm punch

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