PREFERRED MEDICAL PRODUCTS, LLC - STERILE DISPOSABLE EQUIPMENT COVER - FLAT POLY - PREFERRED MEDICAL PRODUCTS, LLC

Duns Number:161770292

Device Description: STERILE DISPOSABLE EQUIPMENT COVER - FLAT POLY BAG 36" X 38"

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


More Product Details

Catalog Number

NB-3638

Brand Name

PREFERRED MEDICAL PRODUCTS, LLC

Version/Model Number

NB-3638

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K863853,K863853,K863853

Product Code Details

Product Code

JAA

Product Code Name

System, X-Ray, Fluoroscopic, Image-Intensified

Device Record Status

Public Device Record Key

7705907d-c74c-4ceb-ace7-ae41aaa93e9c

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

March 21, 2017

Additional Identifiers

Package DI Number

30680211002669

Quantity per Package

100

Contains DI Package

00680211002668

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"PREFERRED MEDICAL PRODUCTS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 47