ManaEZ Wrist Right, Extra Large EZW3908R-XL

GUDID 00810113684178

The ManaEZ wrist is a high quality, wrist brace. Patent pending single pull system makes it easier for the user to self-apply the brace. Low-profile, high-quality lace design system This is the Extra-Large version to accommodate patients who do not fit the one-size-fits-most orthosis.

Manamed, Inc.

Wrist splint, reusable
Primary Device ID00810113684178
NIH Device Record Key7e1a8216-3a79-4641-aa92-a5ee7a84c790
Commercial Distribution StatusIn Commercial Distribution
Brand NameManaEZ Wrist Right, Extra Large
Version Model NumberEZW3908R-XL
Catalog NumberEZW3908R-XL
Company DUNS084042331
Company NameManamed, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810113684178 [Primary]

FDA Product Code

ILHSplint, Hand, And Components

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2026-02-09
Device Publish Date2025-10-17

Devices Manufactured by Manamed, Inc.

00810113684154 - ManaEZ Wrist Left, Extra Large 2026-02-09 The ManaEZ wrist is a high quality, wrist brace. Patent pending single pull system makes it easier for the user to self-apply th
00810113684161 - ManaEZ Wrist Left, Extra Small2026-02-09 The ManaEZ wrist is a high quality, wrist brace. Patent pending single pull system makes it easier for the user to self-apply th
00810113684178 - ManaEZ Wrist Right, Extra Large 2026-02-09The ManaEZ wrist is a high quality, wrist brace. Patent pending single pull system makes it easier for the user to self-apply the brace. Low-profile, high-quality lace design system This is the Extra-Large version to accommodate patients who do not fit the one-size-fits-most orthosis.
00810113684178 - ManaEZ Wrist Right, Extra Large 2026-02-09 The ManaEZ wrist is a high quality, wrist brace. Patent pending single pull system makes it easier for the user to self-apply th
00810113684185 - ManaEZ Wrist Right, Extra Small2026-02-09 The ManaEZ wrist is a high quality, wrist brace. Patent pending single pull system makes it easier for the user to self-apply th
00810113683065 - ManaEZ ROM Ice Short2026-01-12 ManaEZ ROM Ice is a quick fitting, universal, knee range of motion orthosis with compression and a flexible ice pack. The brace
00810113683515 - ManaEZ Hip Ice CureTech2026-01-12 ManaEZ Hip Ice is a quick fitting, universal, hip range of motion orthosis. The brace includes range of motion hinges to allow f
00810113683522 - ManaEZ ROM Ice CureTech2026-01-12 ManaEZ ROM is a quick fitting, universal, knee range of motion orthosis. The brace includes range of motion hinges to allow for
00810113683539 - ManaEZ Shoulder Ice CureTech2026-01-12 The ManaEZ Shoulder ice a convenient shoulder orthosis for pain, swelling, and to compress the shoulder joint. Pump up with air

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