Custom Procedure Kit - MEDIVATORS INC.

Duns Number:068199363

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More Product Details

Catalog Number

-

Brand Name

Custom Procedure Kit

Version/Model Number

4004541

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

MNL

Product Code Name

Accessories, Cleaning Brushes, For Endoscope

Device Record Status

Public Device Record Key

75fc606f-585a-4126-bff3-70619dd1bc44

Public Version Date

April 27, 2022

Public Version Number

3

DI Record Publish Date

November 12, 2021

Additional Identifiers

Package DI Number

40677964026315

Quantity per Package

10

Contains DI Package

40677964026308

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MEDIVATORS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2999
2 A medical device with a moderate to high risk that requires special controls. 362