Reusable Kit FP-46989

GUDID 00850470007234

RESTORATION ROBOTICS, INC.

Hair extraction punch
Primary Device ID00850470007234
NIH Device Record Keya3edd6cd-a526-4633-bf89-0ccaef821fa7
Commercial Distribution StatusIn Commercial Distribution
Brand NameReusable Kit
Version Model Number18G/19G
Catalog NumberFP-46989
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850470007234 [Primary]

FDA Product Code

ONAComputer Assisted Hair Harvesting System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850470007234]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-17

On-Brand Devices [Reusable Kit]

00850470007241Site Making
0085047000723418G/19G

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