InstaRay 02HAM15302

GUDID 00858475006184

Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.

DENTERPRISE INTERNATIONAL, INC.

Dental digital imaging sensor, intraoral
Primary Device ID00858475006184
NIH Device Record Key24e4dc84-ddbc-4757-ae2d-4686ae26a50f
Commercial Distribution StatusIn Commercial Distribution
Brand NameInstaRay
Version Model NumberSize 2
Catalog Number02HAM15302
Company DUNS024913248
Company NameDENTERPRISE INTERNATIONAL, INC.
Device Count1
DM Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-877-509-3180
Emailinfo@denterpriseintl.com
Phone1-877-509-3180
Emailinfo@denterpriseintl.com
Phone1-877-509-3180
Emailinfo@denterpriseintl.com
Phone1-877-509-3180
Emailinfo@denterpriseintl.com
Phone1-877-509-3180
Emailinfo@denterpriseintl.com
Phone1-877-509-3180
Emailinfo@denterpriseintl.com
Phone1-877-509-3180
Emailinfo@denterpriseintl.com
Phone1-877-509-3180
Emailinfo@denterpriseintl.com
Phone1-877-509-3180
Emailinfo@denterpriseintl.com
Phone1-877-509-3180
Emailinfo@denterpriseintl.com
Phone1-877-509-3180
Emailinfo@denterpriseintl.com
Phone1-877-509-3180
Emailinfo@denterpriseintl.com
Phone1-877-509-3180
Emailinfo@denterpriseintl.com
Phone1-877-509-3180
Emailinfo@denterpriseintl.com
Phone1-877-509-3180
Emailinfo@denterpriseintl.com
Phone1-877-509-3180
Emailinfo@denterpriseintl.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858475006184 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUHSystem, X-Ray, Extraoral Source, Digital

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-01
Device Publish Date2019-07-24

On-Brand Devices [InstaRay]

00858475006184Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw and o
00858475006177Size 1

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