HAPAD HIGH HEEL HELPERS HHHXL

GUDID 00082147001027

HAPAD INC

Orthotic insole, prefabricated, non-antimicrobial
Primary Device ID00082147001027
NIH Device Record Keyc5c8e378-a13d-45ad-9abc-f6399438c9e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAPAD HIGH HEEL HELPERS
Version Model NumberWOMENS 12-13
Catalog NumberHHHXL
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
GS100082147001027 [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 HIGH HEEL HELPERS]

00082147001041WOMENS 4 1/2 - 51/2
00082147001034WOMENS 6-7
00082147001027WOMENS 12-13
00082147001010WOMENS 7 1/2 - 81/2
00082147001003WOMENS 9-10
00082147000990WOMENS 10 1/2 - 11 1/2

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