ManaMed

FDA UDI

Class I (US FDA UDI)

by Manamed Llc

Identity

Trade Name: ManaMed FDA UDI
Generic Name: Lumbar spine orthosis FDA UDI
Device Name: The Tailback 64 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, spine motion restriction, comfortable, and quick fitting solution for every patient. Ice pack included. Easy application, universal size TLSO Thoracic bar with height adjustments Lightweight, latex-free breathable material Single pulley system FDA UDI
Model / Reference: Tailback 64 FDA UDI
Description: The Tailback 64 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, spine motion restriction, comfortable, and quick fitting solution for every patient. Ice pack included. Easy application, universal size TLSO Thoracic bar with height adjustments Lightweight, latex-free breathable material Single pulley system FDA UDI

Identifiers

Catalog Number: TB064 FDA UDI
Primary DI / UDI-DI: 00810113681931 FDA UDI
FDA Product Code: IPT FDA UDI
IQE FDA UDI
GMDN Term: Lumbar spine orthosis FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3490 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Lumbar spine orthosis Multiple spinal region orthosis Thoracic spine orthosis

ManaMed by Manamed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Manamed Llc

Sources (1)

FDA UDI c9ade847-e250-4248-8afb-d7b886207dde 34 fields · synced May 31, 2026