Universal Holders

GUDID D764B10730621

UNIVERSAL HOLDERS STARTER KIT

SIRONA DENTAL, INC.

Dental x-ray film holder, reusable
Primary Device IDD764B10730621
NIH Device Record Key89d95706-8e7b-4d94-9dd7-53245bfa1515
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal Holders
Version Model NumberB1073062
Company DUNS078613913
Company NameSIRONA DENTAL, INC.
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800.659.5977
Emailimagingsupportus@dentsplysirona.com
Phone800.659.5977
Emailimagingsupportus@dentsplysirona.com
Phone800.659.5977
Emailimagingsupportus@dentsplysirona.com
Phone800.659.5977
Emailimagingsupportus@dentsplysirona.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD764B10730621 [Primary]

FDA Product Code

OFXGeneral Purpose Dental Tray

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-15
Device Publish Date2022-12-07

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D764B10730621UNIVERSAL HOLDERS STARTER KIT

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