FDA.report

External Drainage Set

Primary DI
30381780035552
Brand
External Drainage Set
Company
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
Model
910116D
Catalog number
910116D
Device description
6 Drainable Collection Bags, 500 ml, with female Luer-lock connector, a suspension hook, and a hydrophobic filter.
Published
2015-10-01
Public version status
Update
Distribution status
Not 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
30381780035552PackageGS16Not in Commercial Distribution
10381780035558PrimaryGS10
M272910116D1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3038178003555230381780035552
1038178003555810381780035558

GMDN Terms

TermDefinition
Cerebrospinal fluid external drainage kitA collection of sterile devices intended to be used with an intracerebral or spinal infusion/drainage catheter (not included) to collect drained cerebrospinal fluid (CSF), and other fluids of similar physical characteristics, from the brain ventricles or from the lumbar subarachnoid (intrathecal) region as a means of reducing CSF volume and intracranial pressure (ICP). It typically includes devices such as a drip chamber, drainage bag, tubing set, catheter connector, stopcock, and filter. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags

DUNS number
531408342
Device count
1
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

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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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