Model: 3
DI: B214OSPTMV30
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2022-12-08
Current Version: 2026-05-19
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
4
Record Key:
6da5bd10-c978-43db-91af-e1c7d53b0bf8
Distribution Status:
In Commercial Distribution
DUNS Number:
486330728
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
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:
B214OSPTMV30
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code:
Name:
FDA Product Codes
KGI
Densitometer, Bone