Philips Zoom

GUDID 00075020035011

Discus Dental, LLC

Tooth-bleaching acceleration unit
Primary Device ID00075020035011
NIH Device Record Key37a52c04-3932-43c3-9640-06a04683e9b9
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhilips Zoom
Version Model NumberDIS558/01
Company DUNS831726109
Company NameDiscus Dental, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100075020035011 [Primary]

FDA Product Code

IWSShield, eye, radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-01
Device Publish Date2020-09-23

On-Brand Devices [Philips Zoom]

08710103632092DIS574/01
08710103632085DIS573/01
00075020044129DIS716/01
08710103632122DIS578/01
00075020035011DIS558/01
08710103611967DIS203/30

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