Model: 7070042
Catalog: 7070042
DI: 00887517413673
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-25
Current Version: 2026-05-04
Description
MAS PLIF Fixation Insulator, Drill/Tap
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:
7334b4c7-c44a-42ac-afa7-1fbdb2db0cd8
Distribution Status:
In Commercial Distribution
DUNS Number:
053950783
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00887517413673
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 64192
Name: Internal spinal fixation procedure kit, reusable
Definition:
A collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a reusable device.
FDA Product Codes
ETN
STIMULATOR, NERVE
Premarket Submissions
Submission Number:
K112709
Supplement Number:
000