SurgiPro 5701732

GUDID 00304040125663

Air Powered Highspeed Surgical Handpiece

HENRY SCHEIN, INC.

Dental power tool system handpiece, pneumatic
Primary Device ID00304040125663
NIH Device Record Key87fe787f-c18b-4868-b454-3aeebd3461aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgiPro
Version Model Number5701732
Catalog Number5701732
Company DUNS012430880
Company NameHENRY SCHEIN, 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 Usefalse
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
GS100304040125663 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EFBHandpiece, air-powered, dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-10
Device Publish Date2020-01-31

On-Brand Devices [SurgiPro]

00304040125687Air Powered Highspeed Surgical Handpiece
00304040125670Air Powered Highspeed Surgical Handpiece
00304040125663Air Powered Highspeed Surgical Handpiece

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