Medovations® InnerVision® - Detachable Tips for Fiber Optic Cable, 56 French - DIVERSATEK HEALTHCARE, INC.

Duns Number:030650113

Device Description: Detachable Tips for Fiber Optic Cable, 56 French

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

1465-56

Brand Name

Medovations® InnerVision®

Version/Model Number

1465-56

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

-

For Single-Use

Yes

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

FDG

Product Code Name

Retractor, Fiberoptic

Device Record Status

Public Device Record Key

918af718-c971-4779-be04-80167d8b3ba8

Public Version Date

April 10, 2019

Public Version Number

4

DI Record Publish Date

September 18, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIVERSATEK HEALTHCARE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 109
2 A medical device with a moderate to high risk that requires special controls. 207