Model: 457856
Catalog: 457856
DI: 04035479170295
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-28
Current Version: 2026-06-05
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2d30abb9-82b9-4df0-8a13-414e32db889b
Distribution Status:
In Commercial Distribution
DUNS Number:
315620229
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
04035479170295
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 46801
Name: Subcutaneous tunneller, single-use
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). 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.
FDA Product Codes
LGW
Stimulator, spinal-cord, totally implanted for pain relief
Premarket Submissions
Submission Number:
P210037
Supplement Number:
012
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Fahrenheit
Storage Handling - Storage Handling Low - @attributes - Value:
14
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Fahrenheit
Storage Handling - Storage Handling High - @attributes - Value:
131
Storage Handling - Storage Handling Type:
Storage Environment Temperature