FDA UDI In Commercial Distribution 🇺🇸 United States

ManaMed

DI: 00810113681900 · Model: Tailback 50 · MANAMED INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ManaMed
Primary DI
00810113681900
Version / Model
Tailback 50
Catalog Number
TB050
Company Name
MANAMED INC
Labeler DUNS
084042331
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-06-20
Public Version
1
Public Version Date
2022-06-28
Public Version Status
New
Public Device Record Key
f543666a-1753-4f31-ae57-183d98e05d26

Device Description

The Tailback 50 is a universal spinal orthosis designed with our patent pending chord compression system with center hub compression technology. It is designed to provide a rigid, comfortable, and quick fitting solution for every patient. Ice pack included. Easy application, universal size Removable ice pack Lightweight, latex free breathable material Single pulley system

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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

GMDN Terms

Code Name
33031 Lumbar spine orthosis

Identifiers

Type ID
Primary 00810113681900