Model: FG1-15-140450
Catalog: FG1-15-140450
DI: 00840493421773
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Description
Z-ROD, 5.5mm x 450mm
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:
c0c1f904-14ba-4c1f-b4ca-d158ae38d580
Distribution Status:
In Commercial Distribution
DUNS Number:
080386764
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:
00840493421773
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 65166
Name: Operating table patient pressure distribution monitor
Definition:
An electronic device designed to continuously measure and display a patient’s body pressure distribution on a pressure-sensing operating table mattress during a surgical procedure. It is typically in the form of a portable tablet with dedicated software which wirelessly receives data from the pressure-sensing mattress or a data recording hub.
FDA Product Codes
NKB
Thoracolumbosacral Pedicle Screw System
KWQ
Appliance, Fixation, Spinal Intervertebral Body
OLO
Orthopedic Stereotaxic Instrument
Premarket Submissions
Submission Number:
K251154
Supplement Number:
000