AimRight

GUDID D7641000053301

AimRight Sensor Holder, BW-Red S1 2PC

SIRONA DENTAL, INC.

Dental x-ray film holder, reusable
Primary Device IDD7641000053301
NIH Device Record Keyae033d7b-77c1-4797-8f9b-22b2ec01cbaf
Commercial Distribution StatusIn Commercial Distribution
Brand NameAimRight
Version Model Number100005330
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 Batchfalse
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
HIBCCD7641000053301 [Primary]

FDA Product Code

EGZHolder, Film, X-Ray

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

On-Brand Devices [AimRight]

D7641000053451AIMRIGHT ADHESIVE HOLDERS SAMPLER
D7641000053341AimRight Aiming Ring, Red 1 PC
D7641000053331AimRight Sensor Holder, ANT-Blue S2 2PC
D7641000053321AimRight Sensor Holder, ANT-Blue S1 2PC
D7641000053311AimRight Sensor Holder, BW-Red S2 2PC
D7641000053301AimRight Sensor Holder, BW-Red S1 2PC
D7641000053251AimRight Sensor Holder, PA-Yel. S2 4pc
D7641000053241AimRight Sensor Holder, PA-Yel. S1 4pc

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