Model: SUP3134BLK
DI: 00810178888092
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
627 Ultra LSO
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c5844507-9e9c-4577-ba09-09e1e5fdbe75
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:
00810178888092
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 33031
Name: Lumbar spine orthosis
Definition:
A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable device.
FDA Product Codes
IPT
Orthosis, Thoracic