ACUITY™

GUDID 08714729936176

Universal Cutter

BOSTON SCIENTIFIC CORPORATION

Intravascular catheter slitter Intravascular catheter slitter Intravascular catheter slitter
Primary Device ID08714729936176
NIH Device Record Keyaa502831-6efb-416a-bb22-b5402e95a196
Commercial Distribution StatusIn Commercial Distribution
Brand NameACUITY™
Version Model Number7060
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
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
GS108714729936176 [Primary]
GS108714729936176 [Primary]
GS108714729936176 [Primary]

FDA Product Code

DQYCATHETER, PERCUTANEOUS
DQYCATHETER, PERCUTANEOUS
DQYCATHETER, PERCUTANEOUS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-05-19
Device Publish Date2016-09-24

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

08714729960140 - Comet™ II2020-05-21 Pressure Guidewire
08714729936176 - ACUITY™2020-05-19Universal Cutter
08714729936176 - ACUITY™2020-05-19 Universal Cutter
08714729990901 - EXALT™2020-05-19 Controller
08714729990925 - EXALT™2020-05-19 Controller
08714729990932 - EXALT™2020-05-19 Controller
08714729990956 - EXALT™2020-05-19 Controller
00802526610400 - NA2020-05-13 BATTERY
00802526610615 - NA2020-05-13 STERILZABLE TELEMETRY WAND

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