PRO ADVANTAGE - PRO ADVANTAGE PILLOWCASE 21X30 T/P 100/CS - NATIONAL DISTRIBUTION & CONTRACTING, INC.

Duns Number:009831413

Device Description: PRO ADVANTAGE PILLOWCASE 21X30 T/P 100/CS

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


More Product Details

Catalog Number

P230023

Brand Name

PRO ADVANTAGE

Version/Model Number

P230023

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)

Yes

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

KHR

Product Code Name

Absorber, Saliva, Paper

Device Record Status

Public Device Record Key

376e4ce5-d385-4a8b-a142-b120403cf3d1

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 14, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NATIONAL DISTRIBUTION & CONTRACTING, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 224
2 A medical device with a moderate to high risk that requires special controls. 192