HAPAD COMF-ORTHOTIC 3/4 LENGTH WOOL FELT INSOLE COMM

GUDID 00082147000051

HAPAD INC

Orthotic insole, prefabricated, non-antimicrobial
Primary Device ID00082147000051
NIH Device Record Key82c8c92e-f870-48dd-bd84-c1b5b710e292
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAPAD COMF-ORTHOTIC 3/4 LENGTH WOOL FELT INSOLE
Version Model NumberMENS 9-9 1/2
Catalog NumberCOMM
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-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100082147000051 [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

On-Brand Devices [HAPAD COMF-ORTHOTIC 3/4 LENGTH WOOL FELT INSOLE]

00082147000204PEDIATRIC SIZE 10-11 1/2
00082147000198PEDIATRIC SIZE 12- 13 1/2
00082147000181PEDIATRIC SIZE 1-2 1/2
00082147000174PEDIATRIC SIZE 3-4 1/2
00082147000167MENS 5-6 1/2
00082147000150WOMENS 4 1/2 - 5 1/2
00082147000143WOMENS 10 1/2 - 11 1/2
00082147000136WOMENS 6-7
00082147000129WOMENS 7 1/2 - 81/2
00082147000112WOMENS 9-10
00082147000105MENS 7-8 1/2 EEE
00082147000099MENS 15-16 1/2
00082147000082MENS 13-14 1/2
00082147000075MENS 7-8 1/2
00082147000068MENS 10-11
00082147000051MENS 9-9 1/2
00082147000044MENS 11 1/2-12 1/2
00082147000037MENS10-11 EEE
00082147000020MENS 9-9 1/2 EEE
00082147000013MENS 11 1/2-12 1/2 EEE
00082147000006MENS 13-14 1/2 EEE
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.