Licox®

Primary DI
M273IT21
Brand
Licox®
Company
GMS, Gesellschaft für medizinische Sondentechnik mbH
Model
IT2
Catalog number
IT2
Device description
Licox® Complete Brain Tunnelling Probe Kit
Published
2015-10-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GWMDEVICE, MONITORING, INTRACRANIAL PRESSURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWMDevice, Monitoring, Intracranial PressureNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053244000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053244000LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KITIntegra Lifesciences Corp.2006-05-10GWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780041207PrimaryGS10
M273IT21SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178004120710381780041207

GMDN Terms#

Term, Definition table
TermDefinition
Intracerebral sensor catheterA flexible tube with a sensor at the distal end intended to be surgically inserted through the skull for short-term (= 30 days) access to the ventricular and/or parenchymal areas of the brain to measure intracranial parameters [e.g., intracranial pressure (ICP), temperature, partial pressure of oxygen (pO2)]; it may in addition be intended for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents, radioisotopes). It may include accessory devices intended to facilitate catheter introduction, stabilization, and/or fluid collection/infusion (e.g., stylet, bolts, drills, drainage/infusion port/reservoir). 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
Handling Environment Temperature2 Degrees Celsius10 Degrees Celsius
Special Storage Condition, Specify00Keep Away From Sunlight

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315902197
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780041078Licox®CC1P1CC1P12015-10-01
10381780041122Licox®IP1IP12015-10-01
10381780041139Licox®IP2IP22015-10-01
10381780041184Licox®IP1PIP1P2015-10-01
10381780041191Licox®IP2PIP2P2015-10-01
10381780041221Licox®BC10PMOBC10PMO2015-10-01
10381780041399Licox®PMOBOXPMOBOX2017-10-09
10381780041405Licox®PMOCABPMOCAB2015-10-01
10381780041412Licox®PMOFCPMOFC2017-10-09
10381780041429Licox®PMOPSTPMOPST2017-10-09
10381780041436Licox®VK52VK522015-10-01
M273IP11Licox®IP1IP12015-10-01
M273IP21Licox®IP2IP22015-10-01
M273BC10PMO0Licox®BC10PMOBC10PMO2015-10-01
M273PMOCAB0Licox®PMOCABPMOCAB2015-10-01
M273PMOFC0Licox®PMOFCPMOFC2017-10-09
M273PMOPST0Licox®PMOPSTPMOPST2017-10-09
10381780041108Licox®IM2IM22015-10-01
10381780041115Licox®IM3IM32015-10-01
10381780041153Licox®IM2SIM2S2015-10-01

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Primary DI, Brand, Company table
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00763000281229Exacta Pole Clamp with laser levelMEDTRONIC PS MEDICAL, INC.GWM2025-02-16
00763000467401NAMEDTRONIC PS MEDICAL, INC.GWM2024-06-01
00763000406073BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-03-31
20763000467344NAMEDTRONIC PS MEDICAL, INC.GWM2024-03-01
20763000467351NAMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
20763000467382NAMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
20763000467399NAMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000406080NAMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000431259BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000529307BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000529369BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000572877BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-02-25
00850013266203IRRAflow Tube SetClearpoint Neuro, Inc.GWM2023-11-02
00763000624774Duet®MEDTRONIC PS MEDICAL, INC.GWM2022-03-10
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00763000428723Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000428747Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000428754Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000428761Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000428778Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000431273Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-13
20763000431307N/AMEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000395971Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000395988N/AMEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000406004Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000406011Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-07