Model: SUP3145BLK
DI: 00810178889266
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-05
Current Version: 2026-05-13
Description
467 TLSO Essential
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
821deefa-1d81-43c1-a8fb-e176115b0085
Distribution Status:
In Commercial Distribution
DUNS Number:
047025993
Device Count:
1
DM Exempt:
Yes
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:
00810178889266
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 41042
Name: Thoracic spine orthosis
Definition:
A prefabricated (non-customized) orthopaedic corset designed to encompasses the thoracic spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine through compression of the abdomen. This is a reusable device.
FDA Product Codes
IPT
Orthosis, Thoracic