Precision Tunneler - Small

Primary DI
00866614000153
Brand
Precision Tunneler - Small
Company
ARKIS BIOSCIENCES INC.
Model
41.020.501
Catalog number
41.020.501
Device description
The Arkis Precision Tunneler is designed to facilitate the subcutaneous passage of shunt tubing between two skin incisions when implanting a ventricular shunting system in patients with normal skin.
Published
2018-12-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866614000153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866614000153008666140001538666140001530866614000153

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8442475383customerservice@arkisbiosciences.com
+1(800)654-2873custserv@integralife.com

Regulatory Flags#

DUNS number
078846878
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10866614000181Subcutaneous Guidewire - Medium41.240.50241.240.5022018-12-14
10866614000198Subcutaneous Guidewire - Large41.240.50341.240.5032018-12-14
10866614000105CerebroFlo EVD Catheter Set37.550.50137.550.5012019-10-24
00866614000115Galea Elevator41.312.10141.312.1012019-04-25
00866614000108CerebroFlo EVD Catheter Set37.550.10137.550.1012017-12-15
00866614000122Single Pass Tunneling Guidewire - Large41.157.10341.157.1032018-12-14
00866614000139Single Pass Tunneling Guidewire - Medium41.157.10241.157.1022018-12-14
00866614000146Single Pass Tunneling Guidewire - Small41.157.10141.157.1012018-12-14
00866614000160Precision Tunneler - Medium41.020.50241.020.5022018-12-13
00866614000177Precision Tunneler - Large41.020.50341.020.5032018-12-13

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