Medi-Cut Blades #11 - DYNAREX CORPORATION

Duns Number:008124539

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More Product Details

Catalog Number

-

Brand Name

Medi-Cut Blades #11

Version/Model Number

4131

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)

-

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

GES

Product Code Name

Blade, Scalpel

Device Record Status

Public Device Record Key

5295a43a-96c0-4909-a4d3-d2b65ae5b4a4

Public Version Date

April 25, 2022

Public Version Number

1

DI Record Publish Date

April 17, 2022

Additional Identifiers

Package DI Number

00616784413136

Quantity per Package

10

Contains DI Package

00616784413129

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Shipper

"DYNAREX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 694
2 A medical device with a moderate to high risk that requires special controls. 226
3 A medical device with high risk that requires premarket approval 2