Model: CS 3930
DI: 04052536085491
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-28
Current Version: 2026-06-05
Description
Depth gauge
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:
c111d31d-c740-43ff-8265-ec748928c8ce
Distribution Status:
In Commercial Distribution
DUNS Number:
315494757
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:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
04052536085491
Type:
Primary
Issuing Agency:
GS1
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
NKG
Posterior Cervical Screw System
KWP
Appliance, Fixation, Spinal Interlaminal
Premarket Submissions
Item #1 - Submission Number:
K150650
Item #1 - Supplement Number:
000
Item #2 - Submission Number:
K161032
Item #2 - Supplement Number:
000