FDA.reportPublic FDA data

Subcutaneous Guidewire - Large

Primary DI
10866614000198
Brand
Subcutaneous Guidewire - Large
Company
ARKIS BIOSCIENCES INC.
Model
41.240.503
Catalog number
41.240.503
Device description
The Subcutaneous Guidewire is designed to facilitate the subcutaneous passage of tubing, suture, ribbons, and/or bands between two skin incisions. It is also designed to facilitate the subcutaneous passage of shunt tubing when implanting a ventricular or lumbar cerebrospinal fluid (CSF) shunting system or externalized CSF drain.
Published
2018-12-14
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
HAOInstrument, Surgical, Non-Powered
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYKInstrument, Shunt System ImplantationNeurology1
HAOInstrument, Surgical, Non-PoweredNeurology1
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10866614000198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1086661400019810866614000198

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
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
00866614000153Precision Tunneler - Small41.020.50141.020.5012018-12-13
00866614000160Precision Tunneler - Medium41.020.50241.020.5022018-12-13
00866614000177Precision Tunneler - Large41.020.50341.020.5032018-12-13

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