TGA-TENNIS ELBOW GEL/AIR XLONG

GUDID 00840314815125

TGA-TENNIS ELBOW GEL/AIR XLONG SKU HM7426

Hausmann Enterprises, LLC

Elbow orthosis
Primary Device ID00840314815125
NIH Device Record Key67abf8c1-3f08-4883-ad46-818547ea35b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameTGA-TENNIS ELBOW GEL/AIR XLONG
Version Model NumberHM7426
Company DUNS001892660
Company NameHausmann Enterprises, LLC
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 Usetrue
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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840314815125 [Primary]

FDA Product Code

IQIOrthosis, Limb Brace

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-10
Device Publish Date2025-01-31

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