Natus®

Primary DI
00382830054119
Brand
Natus®
Company
NATUS MEDICAL INCORPORATED
Model
NT901118
Catalog number
NT901118
Device description
PERITONEAL INTRODUCER SHEATHS, 46 cm
Published
2020-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GYKInstrument, Shunt System Implantation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYKInstrument, Shunt System ImplantationNeurology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K771529000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K771529000PERITONEAL INTRODUCER & SHEATHCordis Corp.1977-08-16GYK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382830057363PackageGS15In Commercial Distribution
10381780033172PreviousGS10
00382830054119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382830057363003828300573633828300573630382830057363
1038178003317210381780033172
00382830054119003828300541193828300541190382830054119

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous tunneller, single-useA hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues and is not a dedicated pacing or defibrillation lead tunneller. This is a single-use device.

Device Sizes#

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

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00382830045278Echo-Screen III ProEchoScreen III Refurbished, DPOAE with barcode023481R2020-02-20
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
00382830000727NATUS MEDICAL2032002016-10-26
00382830000734Bio-logicOAE Foam Tip Pediatric203201, 294252016-12-30
00382830000741Bio-logicOAE Foam Tip Adult203202, 294272017-03-31
00382830000758Bio-logicOAE Tree Tip203208, 294212017-03-31
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
00382830000871Natus Silver Disc Electrode Silicone1010012017-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760124138092SophysaSOPHYSAGYK2026-06-05
03760124138108SophysaSOPHYSAGYK2026-06-05
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03760124131451SophysaSOPHYSAGYK2023-06-02
03760124131444SophysaSOPHYSAGYK2023-06-02
13760124131458SophysaSOPHYSAGYK2023-06-02
03760124131468SophysaSOPHYSAGYK2023-06-02
03760124131475SophysaSOPHYSAGYK2023-06-02
04041906505530AESCULAPAesculap AGGYK2023-04-03
04041906505547AESCULAPAesculap AGGYK2023-04-03
04041906505554AESCULAPAesculap AGGYK2023-04-03
04041906505561AESCULAPAesculap AGGYK2023-04-03
04041906505578AESCULAPAesculap AGGYK2023-04-03
04041906505585AESCULAPAesculap AGGYK2023-04-03
04041906505592AESCULAPAesculap AGGYK2023-04-03
04041906505608AESCULAPAesculap AGGYK2023-04-03
04041906507336AESCULAPAesculap AGGYK2023-04-03
04041906507343AESCULAPAesculap AGGYK2023-04-03
04041906507350AESCULAPAesculap AGGYK2023-04-03
04041906507367AESCULAPAesculap AGGYK2023-04-03
04041906507374AESCULAPAesculap AGGYK2023-04-03
04041906507381AESCULAPAesculap AGGYK2023-04-03
04041906507398AESCULAPAesculap AGGYK2023-04-03
04041906507404AESCULAPAesculap AGGYK2023-04-03
00763000031268N/AMEDTRONIC PS MEDICAL, INC.GYK2020-07-20
00382830057325Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-17
00382830057332Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-17