Device
4mm, 66cm, New Catheter Passer, Shunt Guide w/Hole in tip and T-handle (Reusable Stainless Steel)
Manufacturer
Avalign Technologies, Inc.
Avalign Technologies, Inc.
Model: 72-251011SM66
DI: 00190776421007
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
4mm, 66cm, New Catheter Passer, Shunt Guide w/Hole in tip and T-handle (Reusable Stainless Steel)
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
49930e1e-5e03-47ac-8c56-40303e9ad756
Distribution Status:
In Commercial Distribution
DUNS Number:
792528510
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00190776421007
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 46800
Name: Subcutaneous tunneller, reusable
Definition:
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, retinal chip). 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 reusable device intended to be sterilized prior to use.
FDA Product Codes
PIY
Stainless Steel Instrument, Shunt System Implantation