Model: YZM300032
DI: 00810216320348
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
Trial12 10°
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:
55925ee7-79a0-4943-a8a0-392f7dcd6b41
Distribution Status:
In Commercial Distribution
DUNS Number:
105224126
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
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:
00810216320348
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 44788
Name: Spinal implant trial
Definition:
A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.
FDA Product Codes
LXH
Orthopedic Manual Surgical Instrument
Device Sizes
Item #1 - Size - @attributes - Unit:
degree
Item #1 - Size - @attributes - Value:
10
Item #1 - Size Type:
Angle
Item #2 - Size - @attributes - Unit:
Millimeter
Item #2 - Size - @attributes - Value:
12
Item #2 - Size Type:
Height