NeuroBalloon™ 7CBD10

GUDID M2727CBD101

Catheter

Integra LifeSciences Switzerland Sàrl

Neural-tissue balloon catheter
Primary Device IDM2727CBD101
NIH Device Record Keyfd885f88-fbf8-4113-a64d-7a19f2316633
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroBalloon™
Version Model Number7CBD10
Catalog Number7CBD10
Company DUNS480186617
Company NameIntegra LifeSciences Switzerland Sàrl
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780035343 [Primary]
HIBCCM2727CBD101 [Secondary]

FDA Product Code

HAOINSTRUMENT, SURGICAL, NON-POWERED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-09-14
Device Publish Date2016-08-08

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