SpinVision STERILE EQUIPEMENT COVER

GUDID 20845225012681

VOLCANO CORPORATION

Instrument/equipment drape, single-use, sterile Instrument/equipment drape, single-use, sterile Instrument/equipment drape, single-use, sterile Instrument/equipment drape, single-use, sterile Instrument/equipment drape, single-use, sterile Instrument/equipment drape, single-use, sterile Instrument/equipment drape, single-use, sterile Instrument/equipment drape, single-use, sterile Instrument/equipment drape, single-use, sterile Instrument/equipment drape, single-use, sterile Instrument/equipment drape, single-use, sterile Instrument/equipment drape, single-use, sterile Instrument/equipment drape, single-use, sterile Instrument/equipment drape, single-use, sterile Instrument/equipment drape, single-use, sterile Instrument/equipment drape, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use Medical equipment handle cover, single-use Medical equipment handle cover, single-use Medical equipment handle cover, single-use Medical equipment handle cover, single-use Medical equipment handle cover, single-use Medical equipment handle cover, single-use Medical equipment handle cover, single-use Medical equipment handle cover, single-use Medical equipment handle cover, single-use Medical equipment handle cover, single-use Medical equipment handle cover, single-use Medical equipment handle cover, single-use Medical equipment handle cover, single-use Medical equipment handle cover, single-use Medical equipment handle cover, single-use Medical equipment handle cover, single-use
Primary Device ID20845225012681
NIH Device Record Key1d5ea6f6-9618-47a4-992b-363b312adb36
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpinVision STERILE EQUIPEMENT COVER
Version Model Number891BG
Company DUNS135179237
Company NameVOLCANO 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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100845225012687 [Package]
Contains: 10845225012684
Package: Box [10 Units]
In Commercial Distribution
GS110845225012684 [Primary]
GS120845225012681 [Package]
Contains: 10845225012684
Package: Box [80 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KKKSudan Iv
KKXDrape, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-10-26
Device Publish Date2016-09-08

Devices Manufactured by VOLCANO CORPORATION

20845225012681 - SpinVision STERILE EQUIPEMENT COVER2021-10-26
20845225012681 - SpinVision STERILE EQUIPEMENT COVER2021-10-26
20845225012698 - DIGITAL IVUS STERILE EQUIPEMENT COVER2021-10-26
10845225012707 - R-100 STERILE EQUIPEMENT COVER2021-10-26
00845225012915 - IntraSight Mobile2021-02-03
00845225012847 - FM-PIM2021-01-29
00845225012656 - CORE FM CART2020-06-02
00845225010874 - ComboMap Pressure and Flow System 2020-01-01
00845225002565 - Pioneer Plus Catheter2019-03-21

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