FDA.reportPublic FDA data

Luer Lock Connector

Primary DI
10381780034162
Brand
Luer Lock Connector
Company
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
Model
910128
Catalog number
910128
Device description
36 Polycarbonate Luer-Lock Connectors
Published
2015-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
10381780034162PrimaryGS10
M2729101281SecondaryHIBCC0
00381780034165Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178003416210381780034162
00381780034165003817800341653817800341650381780034165

GMDN Terms#

Term, Definition table
TermDefinition
Luer/non-ISO80369-standardized linear connector, single-useA small, non-powered, noninvasive, tubular, two-way/linear connector with a Luer connection (either lock or slip) at one end and a connection which is not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases) at the other end (typically barbed, bayonet, collet, conical, threaded or non-Luer-slip) intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing or an external puncturing component. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
531408342
Device count
36
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
10381780035602Integral Drainage Set910410B910410B2015-10-01
M2729105001Integra®9105002016-08-08
10381780034247Lumbar Catheter9511039511032015-10-01
10381780034582CSF Reservoir9993019993012015-10-01
10381780034599CSF Reservoir9993029993022015-10-01
10381780034605CSF Reservoir9993039993032015-10-01
10381780034612CSF Reservoir9993049993042015-10-01
M27217185C121Integra®17185C122016-08-12
M27217185C161Integra®17185C162016-08-12
M27217185C321Integra®17185C322016-08-12
M27217185C481Integra®17185C482016-08-12
M27217185C641Integra®17185C642016-08-12
M27240M191Integra®40M192016-08-12
M27240M201Integra®40M202016-08-12
M27240M411Auragen™40M412016-08-08
M27240M421Auragen™40M422016-08-08
M27240M431Auragen™40M432016-08-08
M27240M451Auragen™40M452016-08-08
M27240M461Auragen™40M462016-08-08
M27240M471Auragen™40M472016-08-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B775EVACMRI0PHASORPHASOR HEALTH LLCJXG2025-11-24
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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
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