FDA UDI In Commercial Distribution 🇺🇸 United States

Boston Body Jacket, Single Opening

DI: 00860014460807 · Model: Boston Body Jacket, Single Opening · Boston Brace International, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Boston Body Jacket, Single Opening
Primary DI
00860014460807
Version / Model
Boston Body Jacket, Single Opening
Catalog Number
Boston Body Jacket, Single Opening
Company Name
Boston Brace International, Inc.
Labeler DUNS
801816158
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-08-05
Public Version
1
Public Version Date
2025-08-13
Public Version Status
New
Public Device Record Key
e89e026e-8ef7-43e2-9fde-82de7a5133d5

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IQE Orthosis, Lumbar
IPT Orthosis, Thoracic

GMDN Terms

Code Name
66086 Multiple spinal region orthosis

Identifiers

Type ID
Primary 00860014460807