Hayes Handpiece HAHYGENIE

GUDID 00810988030339

HyGenie

HANDPIECE PARTS & REPAIRS, INC.

Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic 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

Devices Manufactured by HANDPIECE PARTS & REPAIRS, INC.

• 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
• 00810988031404 - EDGE ENDO: 2023-04-28 EdgePack 3504 Tip
• 00810988031411 - EDGE ENDO: 2023-04-28 EdgePack 4004 Tip