HAPAD COMF-ORTHOTIC PRO BLUE INSOLES FCCMXXL

GUDID 00082147000365

HAPAD INC

Orthotic insole, prefabricated, non-antimicrobial
Primary Device ID00082147000365
NIH Device Record Key7b10b09f-7b8d-46bb-81cf-a7c7864ee9ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAPAD COMF-ORTHOTIC PRO BLUE INSOLES
Version Model NumberMENS 15+
Catalog NumberFCCMXXL
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
GS100082147000365 [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 PRO BLUE INSOLES]

00082147000419WOMENS 4 1/2 - 5 1/2
00082147000402WOMENS 10 1/2 - 11 1/2
00082147000396WOMENS 6-7
00082147000389WOMENS 7 1/2 - 81/2
00082147000372WOMENS 9-10
00082147000365MENS 15+
00082147000358MENS 5-6 1/2
00082147000341MENS 13- 14 1/2
00082147000334MENS 7-8 1/2
00082147000327MENS 10-11
00082147000310MENS 9-9 1/2
00082147000303MENS 11 1/2 - 12 1/2
00082147000297MENS 10-11 EEE
00082147000280MENS 9-9 1/2 EEE
00082147000273MENS 11 1/2 - 12 1/2 EEE
00082147000266MENS 13-14 1/2 EEE

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