True Support Orthopedic Wrist Brace 1591

GUDID 10891237001598

• Fully adjustable VELCRO allows for universal fit • Ideal treatment for: - Carpal tunnel syndrome - Arthritis - Mild strains or sprains • Provides support to weak or injured wrists • Improves wrist joint function • Available for Right or Left wrist

HOME AIDE DIAGNOSTICS, INC.

Hand/finger splint, single-use
Primary Device ID10891237001598
NIH Device Record Key786bf09f-67f6-499b-999d-7f9a4fed84f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrue Support Orthopedic Wrist Brace
Version Model Number50001-A
Catalog Number1591
Company DUNS783518983
Company NameHOME AIDE DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us

Device Identifiers

Device Issuing AgencyDevice ID
GS100891237001591 [Primary]
GS110891237001598 [Package]
Contains: 00891237001591
Package: Outer Case [150 Units]
In Commercial Distribution

FDA Product Code

ILHSplint, Hand, And Components
IQIOrthosis, Limb Brace

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-07-22
Device Publish Date2018-08-07

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