Hayes Handpiece HAHYGENIE

GUDID 00810988030339

HyGenie

HANDPIECE PARTS & REPAIRS, INC.

Dental power tool system handpiece, pneumatic
Primary Device ID00810988030339
NIH Device Record Key18653f6c-60d1-4f7a-8856-b19f279d3d9f
Commercial Distribution StatusIn Commercial Distribution
Brand NameHayes Handpiece
Version Model NumberHAHYGENIE
Catalog NumberHAHYGENIE
Company DUNS079723355
Company NameHANDPIECE PARTS & REPAIRS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810988030339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EFBHandpiece, Air-Powered, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-21
Device Publish Date2019-11-13

Devices Manufactured by HANDPIECE PARTS & REPAIRS, INC.

00810988030827 - QUALITY PLUS2023-07-25 QUALITY PLUS PEDO 4-HOLE HANDPIECE
00810988031848 - MEDIDENTA2023-07-18 Medidenta Medilectric 40K Brushless/ LED/ Motor Only
00810988031312 - EDGE ENDO2023-04-28 EdgeApex Measuring File
00810988031336 - EDGE ENDO2023-04-28 EdgeApex Measuring Wire
00810988031350 - EDGE ENDO2023-04-28 EdgeApex Tester
00810988031374 - EDGE ENDO2023-04-28 EdgePack Downpack Unit
00810988031404 - EDGE ENDO2023-04-28 EdgePack 3504 Tip
00810988031411 - EDGE ENDO2023-04-28 EdgePack 4004 Tip

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