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ManaMed

FDA UDI

Class I (US FDA UDI)

by Manamed Llc

Identity

Trade Name
ManaMed FDA UDI
Generic Name
Wrist immobilizer, reusable FDA UDI
Device Name
The ManaEZ Thumb Spica is a universal orthosis that includes our patent pending pull system. Low profile, high quality lace design system Universal sizing FDA UDI
Model / Reference
ManaEZ Thumb Spica Universal Left FDA UDI
Description
The ManaEZ Thumb Spica is a universal orthosis that includes our patent pending pull system. Low profile, high quality lace design system Universal sizing FDA UDI

Identifiers

Catalog Number
EZTS3809L FDA UDI
Primary DI / UDI-DI
00850998008188 FDA UDI
FDA Product Code
ILH FDA UDI
GMDN Term
Wrist immobilizer, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3475 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Wrist immobilizer, reusable

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

Similar devices

Also classified as Wrist immobilizer, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Manamed Llc

Sources (1)

  • FDA UDI 8f58e4bb-974e-4c17-83cc-3d319d37ba79 35 fields · synced May 30, 2026