HAPAD COMF-ORTHOTIC WOOL FELT FULL LENGTH INSOLES FCOELEW

GUDID 00082147000679

HAPAD INC

Orthotic insole, prefabricated, non-antimicrobial
Primary Device ID00082147000679
NIH Device Record Key045c305a-780f-4b8b-b069-e4e220312db6
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAPAD COMF-ORTHOTIC WOOL FELT FULL LENGTH INSOLES
Version Model NumberMENS 13-14 1/2 EEE
Catalog NumberFCOELEW
Company DUNS004510525
Company NameHAPAD 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 Batchfalse
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
GS100082147000679 [Primary]

FDA Product Code

KYSInsoles, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-08
Device Publish Date2023-07-31

Devices Manufactured by HAPAD INC

00082147000792 - HAPAD COMF-ORTHOTIC WOOL FELT FULL LENGTH INSOLE2023-10-03
00008214700792 - HAPAD COMF-ORTHOTIC WOOL FELT FULL LENGTH INSOLE2023-08-08
00082147000006 - HAPAD COMF-ORTHOTIC 3/4 LENGTH WOOL FELT INSOLE2023-08-08
00082147000013 - HAPAD COMF-ORTHOTIC 3/4 LENGTH WOOL FELT INSOLE2023-08-08
00082147000020 - HAPAD COMF-ORTHOTIC 3/4 LENGTH WOOL FELT INSOLE2023-08-08
00082147000037 - HAPAD COMF-ORTHOTIC 3/4 LENGTH WOOL FELT INSOLE2023-08-08
00082147000044 - HAPAD COMF-ORTHOTIC 3/4 LENGTH WOOL FELT INSOLE2023-08-08
00082147000051 - HAPAD COMF-ORTHOTIC 3/4 LENGTH WOOL FELT INSOLE2023-08-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.