Model: 18710039
Catalog: 18710039
DI: 03700780634583
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
Screwdriver
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:
f062264c-9150-4f57-a4e1-cbfe78e73e78
Distribution Status:
In Commercial Distribution
DUNS Number:
296568400
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:
03700780634583
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 44054
Name: Orthopaedic surgical procedure kit, non-medicated, reusable
Definition:
A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.
FDA Product Codes
MNH
Orthosis, Spondylolisthesis Spinal Fixation
NKB
Thoracolumbosacral Pedicle Screw System
MNI
Orthosis, Spinal Pedicle Fixation
Premarket Submissions
Submission Number:
K153326
Supplement Number:
000