Primary Device ID | M2727CBD101 |
NIH Device Record Key | fd885f88-fbf8-4113-a64d-7a19f2316633 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | NeuroBalloon™ |
Version Model Number | 7CBD10 |
Catalog Number | 7CBD10 |
Company DUNS | 480186617 |
Company Name | Integra LifeSciences Switzerland Sàrl |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10381780035343 [Primary] |
HIBCC | M2727CBD101 [Secondary] |
HAO | INSTRUMENT, SURGICAL, NON-POWERED |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2022-09-14 |
Device Publish Date | 2016-08-08 |
10381780538349 - DirectLink™ | 2024-07-08 DirectLink™ ICP Module |
M2727CBD101 - NeuroBalloon™ | 2022-09-14Catheter |
M2727CBD101 - NeuroBalloon™ | 2022-09-14 Catheter |
10381780034407 - Tuohy Needle | 2022-08-22 The Integra 14G thin wall Tuohy Needle is a single use instrument consisting of a stainless steel cannula, obturator and winged |
M272IM11 - Licox ® | 2022-08-22 Licox® IM1 Single Lumen Introducer Kit is used to insert the Licox® Oxygen probe. It contains: Single lumen Introducer, Guidew |
M272IP11 - Licox ® | 2022-08-22 Licox® IP1 Single Lumen Introducer Kit is used to insert the combined oxygen/temperature probe. It contains: Single lumen Intro |
M272IP21 - Licox ® | 2022-08-22 Licox® IP2 Dual Lumen Introducer Kit contains is used to insert the combined oxygen/temperature probe and the ICP Catheter. It |
10886704079910 - CODMAN® | 2021-09-22 Standard Disposable Non-Stick Bipolar Forceps |
10886704079927 - CODMAN® | 2021-09-22 Standard Disposable Non-Stick Bipolar Forceps |