FDA.report

SHUNTASSISTANT 2.0

Primary DI
04041906501976
Brand
SHUNTASSISTANT 2.0
Company
Aesculap AG
Model
FX135T
Catalog number
FX135T
Device description
SHUNTASSISTANT 2.0 LP/U 35 W/DIST.CATH.
Published
2020-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JXGShunt, central nervous system and components

Product Code Classifications

CodeDeviceSpecialtyClass
JXGShunt, Central Nervous System And ComponentsNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04041906501976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04041906501976040419065019764041906501976

GMDN Terms

TermDefinition
Lumboperitoneal shuntA sterile implantable device intended to divert excessive cerebrospinal fluid (CSF) from the subarachnoid space of the lumbar spine to the peritoneal cavity, where it can be absorbed into the body, as a treatment for elevated intracranial pressure due to increased CSF. It typically consists of fully-implanted interconnected components that include a spinal catheter implanted into the subarachnoid space of the lumbar spine; a mechanical shunt valve that may incorporate a reservoir which can be punctured for sampling/infusion; and a peritoneal catheter implanted into the peritoneal cavity. Disposable devices associated with implantation may be included.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
315018218
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04038653177035AESCULAPOG963ROG963R2016-09-23
04038653242962AESCULAPDF262RDF262R2020-06-17
04038653339563AESCULAPJG901JG9012025-03-22
04038653345038AESCULAPJG910JG9102020-05-20
04038653038244AESCULAPDP511RDP511R2020-06-17
04038653038251AESCULAPDP512RDP512R2020-06-17
04038653038282AESCULAPDP540RDP540R2020-06-17
04038653038299AESCULAPDP541RDP541R2020-06-17
04038653038305AESCULAPDP542RDP542R2020-06-17
04038653177011AESCULAPOG961ROG961R2016-09-23
04038653251407AESCULAPOG960ROG960R2016-09-23
04038653044207MIASPAS MINI-ALIFFF569RFF569R2020-06-17
04038653044214MIASPAS MINI-ALIFFF571RFF571R2020-06-17
04038653044252MIASPAS MINI-ALIFFF578RFF578R2020-06-17
04038653044283MIASPAS MINI-ALIFFF586RFF586R2020-06-17
04038653117307AESCULAPNH196NH1962017-01-27
04038653117352AESCULAPNH206NH2062017-01-27
04038653118540AESCULAPNK088NK0882015-11-11
04038653118557AESCULAPNK089NK0892015-09-24
04038653118564AESCULAPNK090NK0902015-09-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00763000422646StrataMR2MEDTRONIC PS MEDICAL, INC.JXG2026-03-13
00763000422684StrataMR2MEDTRONIC PS MEDICAL, INC.JXG2026-03-13
03760409446294Phoenix NeuroSOPHYSAJXG2025-12-24
B775EVACMRI0PHASORPHASOR HEALTH LLCJXG2025-11-24
10381780521051CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535386CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535409CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535416CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535423CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535904CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535966CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535980CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536000CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536024CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536048CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536062CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536086CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536109CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
B775EVAC0PHASORPHASOR HEALTH LLCJXG2025-06-04
04041906505622XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906505639XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906505646XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506667XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506674XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506681XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506698XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506704XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506711XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506728XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506735XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31