FDA.reportPublic FDA data

Integra®

Primary DI
30381780033176
Brand
Integra®
Company
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
Model
901118
Device description
The 46 cm Peritoneal Introducer Sheath is designed to be used with a Peritoneal Introducer of appropriate length (46 cm) during the placement of a peritoneal drainage catheter in the treatment of hydrocephalus. It features a tapered tip to facilitate subcutaneous insertion and passage.
Published
2016-09-01
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

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
30381780033176PackageGS15Not in Commercial Distribution
10381780033172PrimaryGS10
M2729011181SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3038178003317630381780033176
1038178003317210381780033172

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous tunneller, single-useA sterile, 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. This is a single-use device.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780250371Licox ®VK522016-08-04
10381780023715Integra®910110A910110A2015-10-01
10381780034117External Drainage Set9101092016-06-24
10381780034131Drainage Accessory Kit9101229101222015-10-01
10381780034186Integral Drainage Set9104109104102015-10-01
10381780035541External Drainage Set910116A910116A2015-10-01
10381780035558External Drainage Set910116D910116D2015-10-01
10381780035602Integral Drainage Set910410B910410B2015-10-01
10381780034124Lumbar Catheter Accessory Kit9101219101212015-10-01
10381780034193Integral Drainage Set9104129104122015-10-01
10381780034209Integral Drainage Set9104209104202015-10-01
10381780035527External Drainage Set910112A910112A2015-10-01
10381780035565External Drainage Set910120A910120A2015-10-01
10381780035589External Drainage Set910123A910123A2015-10-01
10381780457305Contour-Flex Valve and Shunt System11811118112018-01-12
10381780457312Contour-Flex Valve and Shunt System11812118122018-01-12
10381780457329Contour-Flex Valve and Shunt System11813118132018-01-12
10381780457459Contour-Flex Valve and Shunt System14085140852018-01-12
10381780457466Contour-Flex Valve and Shunt System14086140862018-01-12
10381780457473Contour-Flex Valve and Shunt System14087140872018-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780537397CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGYK2024-05-29
10381780537403CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGYK2024-05-29
10381780537410CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGYK2024-05-29
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
00382830058193Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-17
00382830058186Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-17
10885403070488V. MuellerCAREFUSION 2200, INCGYK2020-04-15