Medegen Medical products - Drape: Clean Barrier Fields - MEDEGEN MEDICAL PRODUCTS, LLC

Duns Number:055527753

Device Description: Drape: Clean Barrier Fields

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


More Product Details

Catalog Number

68253

Brand Name

Medegen Medical products

Version/Model Number

68253

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

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

K850199,K850199

Product Code Details

Product Code

KKX

Product Code Name

Drape, surgical

Device Record Status

Public Device Record Key

294af36a-1bee-4943-a979-320f848a83c0

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDEGEN MEDICAL PRODUCTS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14
2 A medical device with a moderate to high risk that requires special controls. 108