Hayes Handpiece HAHYGENIE

GUDID 00810988030339

HyGenie

HANDPIECE PARTS & REPAIRS, INC.

Dental power tool system handpiece, pneumatic

• Primary Device ID: 00810988030339
• NIH Device Record Key: 18653f6c-60d1-4f7a-8856-b19f279d3d9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hayes Handpiece
• Version Model Number: HAHYGENIE
• Catalog Number: HAHYGENIE
• Company DUNS: 079723355
• Company Name: HANDPIECE PARTS & REPAIRS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810988030339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073652

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

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

[00810988030339]

Moist Heat or Steam Sterilization

[00810988030339]

Moist Heat or Steam Sterilization

[00810988030339]

Moist Heat or Steam Sterilization

[00810988030339]

Moist Heat or Steam Sterilization

[00810988030339]

Moist Heat or Steam Sterilization

[00810988030339]

Moist Heat or Steam Sterilization

[00810988030339]

Moist Heat or Steam Sterilization

[00810988030339]

Moist Heat or Steam Sterilization

[00810988030339]

Moist Heat or Steam Sterilization

[00810988030339]

Moist Heat or Steam Sterilization

[00810988030339]

Moist Heat or Steam Sterilization

[00810988030339]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-21
• Device Publish Date: 2019-11-13

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• 00810988030827 - QUALITY PLUS: 2023-07-25 QUALITY PLUS PEDO 4-HOLE HANDPIECE
• 00810988031848 - MEDIDENTA: 2023-07-18 Medidenta Medilectric 40K Brushless/ LED/ Motor Only
• 00810988031312 - EDGE ENDO: 2023-04-28 EdgeApex Measuring File
• 00810988031336 - EDGE ENDO: 2023-04-28 EdgeApex Measuring Wire
• 00810988031350 - EDGE ENDO: 2023-04-28 EdgeApex Tester
• 00810988031374 - EDGE ENDO: 2023-04-28 EdgePack Downpack Unit