Model: 35-0013-000
DI: M9433500130000
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
Freedom DS Decompression System
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
4069a7ac-140c-4261-a8f2-2a8796525ed7
Distribution Status:
In Commercial Distribution
DUNS Number:
963359513
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:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
M9433500130000
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 44063
Name: Neurosurgical procedure kit, non-medicated, single-use
Definition:
A collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.
FDA Product Codes
HAE
Rongeur, Manual
HRX
Arthroscope
Premarket Submissions
Submission Number:
K253523
Supplement Number:
000