Natus®

Primary DI
00382830057134
Brand
Natus®
Company
NATUS MEDICAL INCORPORATED
Model
NT8501908
Catalog number
NT8501908
Device description
Pudenz Three-Way Connector
Published
2020-04-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153041000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153041000Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional LabelingIntegra LifeSciences Corporation2016-03-14JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780024378PreviousGS10
00382830057134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178002437810381780024378
00382830057134003828300571343828300571340382830057134

GMDN Terms#

Term, Definition table
TermDefinition
Cerebrospinal fluid shunt connectorA sterile, implantable device intended to connect components of a cerebrospinal fluid (CSF) shunt assembly (e.g., ventriculoperitoneal shunt), designed to remove excess cerebrospinal fluid from around the central nervous system especially in the treatment of hydrocephalus. It is typically made of plastic or metal and is Y-shaped or straight. This is a single-patient device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-356-0007Madison.Helpdesk@Natus.com

Regulatory Flags#

DUNS number
081325959
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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Primary DI, Brand, Model table
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00382830045292Echo-Screen III ProEchoScreen III Refurbished, ABR with barcode023482R2020-02-20
00382830045315Echo-Screen III ProEchoScreen III Refurbished, TEOAE & DPOAE with bar023483R2020-02-20
00382830045339Echo-Screen III ProEchoScreen III Refurbished, TEOAE & ABR with barco023484R2020-02-20
00382830045353Echo-Screen III ProEchoScreen III Refurbished, DPOAE & ABR with barco023485R2020-02-20
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00382830000765Bio-logicOAE Tree Tip Preemie2032092017-03-31
00382830000772Bio-logicOAE Jumbo Tip2032102017-03-31
00382830000789Bio-logicOAE Foam Tip Pediatric203211, 294262016-12-30
00382830000796Bio-logicOAE Foam Tip Adult203212, 294282017-03-31
00382830000819Bio-logicOAE Tree Tip203218, 294222017-03-31
00382830000826Bio-logicOAE Tree Tip Preemie2032192017-03-31
00382830000833Bio-logicOAE 6mm Tip203333, 294232016-12-30
00382830000840Bio-logicOAE 6mm Tip203353, 294242016-12-30
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