Advantage Fit Ultra System M0068502160

GUDID 00191506007669

Transvaginal Mid-Urethral Sling

BOSTON SCIENTIFIC CORPORATION

Stress urinary incontinence surgical mesh, female
Primary Device ID00191506007669
NIH Device Record Keyc6b98e3c-520f-48d9-bd37-fd1a64f2d669
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdvantage Fit Ultra System
Version Model NumberM0068502160
Catalog NumberM0068502160
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
GS100191506007669 [Primary]

FDA Product Code

OTNmesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-14
Device Publish Date2021-10-06

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