HAPAD COMF-ORTHOTIC PRO BLUE INSOLES FCCMS

GUDID 00082147000334

HAPAD INC

Orthotic insole, prefabricated, non-antimicrobial

• Primary Device ID: 00082147000334
• NIH Device Record Key: 0b018dc7-b6df-4d0d-8db4-5c68397605c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAPAD COMF-ORTHOTIC PRO BLUE INSOLES
• Version Model Number: MENS 7-8 1/2
• Catalog Number: FCCMS
• Company DUNS: 004510525
• Company Name: HAPAD INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00082147000334 [Primary]

FDA Product Code

• KYS: Insoles, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-08
• Device Publish Date: 2023-07-31

On-Brand Devices [HAPAD COMF-ORTHOTIC PRO BLUE INSOLES]

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