IRRAflow Laser Leveler Package

Primary DI
10868643000460
Brand
IRRAflow Laser Leveler Package
Company
Irras USA, Inc.
Model
ICLS 010
Catalog number
ICLS 010
Published
2024-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JXGShunt, Central Nervous System And Components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXGShunt, Central Nervous System And ComponentsNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10868643000460PackageGS11In Commercial Distribution
20868643000467PackageGS11In Commercial Distribution
00868643000463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086864300046010868643000460
2086864300046720868643000467
00868643000463008686430004638686430004630868643000463

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, intracranial pressureA small unit dedicated to the detection, measurement, and recording of intracranial pressure (ICP). It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the parameter/information measured and provided by this module.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
056999617
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850013266279IRRAflow Cranial Access BoltICB 0102025-07-24

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Primary DI, Brand, Company table
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03760409441176SophysaSOPHYSAJXG2026-06-05
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03760409441206SophysaSOPHYSAJXG2026-06-05
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