AccessGUDID - DEVICE: Single Pass Tunneling Guidewire

GUDID

Device Identifier (DI) Information

Brand Name: Single Pass Tunneling Guidewire - Large
Version or Model: 41.157.103
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 41.157.103
Company Name: ARKIS BIOSCIENCES INC.

Primary DI Number: 00866614000122
Issuing Agency: GS1
Commercial Distribution End Date: August 26, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 078846878 *Terms of Use

Device Description: The Single Pass Tunneling Guidewire kit is designed to facilitate the subcutaneous passage of shunt tubing from a frontal scalp incision, or an incision on the neck, to an incision site on the torso when implanting a ventricular shunting system in patients greater than five (5) years old with a normal skull and normal skin.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46801	Subcutaneous tunneller, single-use	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GYK	Instrument, Shunt System Implantation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 511f2492-db8f-4120-bded-2ac5d9463362
Public Version Date: March 26, 2024
Public Version Number: 6
DI Record Publish Date: December 14, 2018