Furlow M00635400020

GUDID 00191506022181

Disposable Insertion Tool

BOSTON SCIENTIFIC CORPORATION

Wire/ligature passer, reusable Wire/ligature passer, reusable Wire/ligature passer, reusable Wire/ligature passer, reusable Wire/ligature passer, reusable Wire/ligature passer, reusable Wire/ligature passer, reusable Wire/ligature passer, reusable Wire/ligature passer, reusable Wire/ligature passer, reusable Wire/ligature passer, reusable Penile prosthesis implantation instrument Penile prosthesis implantation instrument Penile prosthesis implantation instrument Penile prosthesis implantation instrument Penile prosthesis implantation instrument Penile prosthesis implantation instrument Penile prosthesis implantation instrument Penile prosthesis implantation instrument Penile prosthesis implantation instrument Penile prosthesis implantation instrument Penile prosthesis implantation instrument Penile prosthesis implantation instrument Penile prosthesis implantation instrument Penile prosthesis implantation instrument Penile prosthesis implantation instrument Penile prosthesis implantation instrument Penile prosthesis implantation instrument
Primary Device ID00191506022181
NIH Device Record Key309e2221-97d4-4d4a-89fe-3a2051e1e64d
Commercial Distribution StatusIn Commercial Distribution
Brand NameFurlow
Version Model NumberM00635400020
Catalog NumberM00635400020
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS100191506022181 [Primary]

FDA Product Code

QGAPenile implant surgical accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-28
Device Publish Date2022-11-18

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