Model: 102001-40
Catalog: DSN-40T
DI: B075102001400
Status: New
MRI: MR Unsafe
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Distribution End: 2026-05-14
Description
Dark Star Navigation Triple Lead Tap - Ø4.0mm
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:
6a7dd6dc-a4be-4950-a485-bef12801f174
Distribution Status:
Not in Commercial Distribution
DUNS Number:
061891717
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
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:
B075102001400
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 44759
Name: General internal orthopaedic fixation system implantation kit
Definition:
A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.
FDA Product Codes
OLO
Orthopedic Stereotaxic Instrument
Premarket Submissions
Submission Number:
K212028
Supplement Number:
000
Device Sizes
Device Size - Size - @attributes - Unit:
Millimeter
Device Size - Size - @attributes - Value:
4.0
Device Size - Size Type:
Outer Diameter