VISTADENT® OC - VISTADENT® OC SUBSCRIPTION EAST - RAINTREE ESSIX INC.

Duns Number:801157132

Device Description: VISTADENT® OC SUBSCRIPTION EAST

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More Product Details

Catalog Number

27-313-99

Brand Name

VISTADENT® OC

Version/Model Number

27-313-99

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2020

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LLZ

Product Code Name

System, image processing, radiological

Device Record Status

Public Device Record Key

d5f6a40a-10fd-4ea8-83dd-3bb1ecfa0e0a

Public Version Date

February 21, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RAINTREE ESSIX INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 66
2 A medical device with a moderate to high risk that requires special controls. 103
U Unclassified 13