FDA.reportPublic FDA data

NeuroBalloon™

Primary DI
10381780035343
Brand
NeuroBalloon™
Company
Integra LifeSciences Switzerland Sàrl
Model
7CBD10
Catalog number
7CBD10
Device description
NeuroBalloon™ NEUROBALLOON™ CATHETER
Published
2016-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAOINSTRUMENT, SURGICAL, NON-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780035343PrimaryGS10
M2727CBD101SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178003534310381780035343

GMDN Terms#

Term, Definition table
TermDefinition
Neural-tissue balloon catheterA sterile, flexible tube with a balloon at the distal tip used for the compression or dilation of neural tissue under direct endoscopic or fluoroscopic vision. It is inserted percutaneously over a metal stylet and typically has a small (mini) diameter with an elongated or a double (figure of 8) balloon; it is made of plastic/silicone materials and may be supplied with the stylet. It is typically used to treat trigeminal neuralgia (controlled balloon compression of the trigeminal ganglion causes selected injury to the insulation on nerve fibres which relieves pain). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do Not Use if Package is Damaged

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
480186617
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780520610DirectLink™82684082-68402020-04-01
10381780520719CODMAN®82688082-68802020-04-01
10381780520726CODMAN®82688182-68812020-04-01
10381780520733CODMAN®82688282-68822020-04-01
10381780542247CODMAN®9190001GF9190001GF2026-04-15
10381780521433Codman VersaTru™9007050ST9007050ST2020-06-02
10381780521457Codman VersaTru™9007100ST9007100ST2020-06-02
10381780521495Codman VersaTru™9008050SL9008050SL2020-06-02
10381780521518Codman VersaTru™9008050ST9008050ST2020-06-02
10381780521532Codman VersaTru™9008100SL9008100SL2020-06-02
10381780521556Codman VersaTru™9008100ST9008100ST2020-06-02
10381780521570Codman VersaTru™9008150SL9008150SL2020-06-02
10381780521631Codman VersaTru™9009050ST9009050ST2020-06-02
10381780521655Codman VersaTru™9009100SL9009100SL2020-06-02
10381780521693Codman VersaTru™9009150SL9009150SL2020-06-02
10381780521716Codman VersaTru™9009150ST9009150ST2020-06-02
10381780521471Codman VersaTru™9007150ST9007150ST2020-06-02
10381780521594Codman VersaTru™9008150ST9008150ST2020-06-02
10381780521617Codman VersaTru™9009050SL9009050SL2020-06-02
10381780521679Codman VersaTru™9009100ST9009100ST2020-06-02

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00724995301996V. MuellerSteris CorporationHAO2026-10-21
00724995302214V. MuellerSTERIS Deutschland GmbHHAO2026-10-21
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04058749126471NAFehling Instruments GmbH & Co. KGHAO2026-10-12
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