Readypak Kit - Readypak Kit - Beaver-Visitec International, Inc.

Duns Number:001406024

Device Description: Readypak Kit

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More Product Details

Catalog Number

-

Brand Name

Readypak Kit

Version/Model Number

584885

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

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

KDD

Product Code Name

Kit, surgical instrument, disposable

Device Record Status

Public Device Record Key

6e6c31aa-9474-4f05-b107-bfb12652bb9f

Public Version Date

October 06, 2021

Public Version Number

3

DI Record Publish Date

April 27, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BEAVER-VISITEC INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 441
2 A medical device with a moderate to high risk that requires special controls. 35
U Unclassified 34