Integra Disposable Peritoneal Catheter Passer

Primary DI
30381780072373
Brand
Integra Disposable Peritoneal Catheter Passer
Company
Integra Lifesciences Corporation
Model
NL8502002
Catalog number
NL8502002
Device description
36CM DISP PASSER PKG ASSY The Disposable Subcutaneous Peritoneal Catheter Passer is a two-component instrument consisting of a stainless tubular shaft with an ULTEM obturator. This product is used to provide a subcutaneous tunnel between the flushing-device site and the incision for the peritoneal catheter. The catheter consists of an open tubular shaft, concentric with a T-handled obturator which extends beyond the tubular shaft. The instrument is passed subcutaneously with the obturator assembled in the tubular shaft. Once the obturator has been removed, the catheter tubing can be passed and the tubular shaft portion of the instrument can be removed in either direction.
Published
2015-09-22
Public version status
Update
Distribution status
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
K895868000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895868000HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSEBaxter Healthcare Corp1989-10-31GYK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30381780072373PackageGS16In Commercial Distribution
10381780072379PrimaryGS10
M269NL85020021SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3038178007237330381780072373
1038178007237910381780072379

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
083171244
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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