PremierPro - OR Towel, 17" x 26" Sterile, Blue - SVS LLC

Duns Number:831375089

Device Description: OR Towel, 17" x 26" Sterile, Blue

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


More Product Details

Catalog Number

8324B

Brand Name

PremierPro

Version/Model Number

8324B

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

KKX

Product Code Name

Drape, Surgical

Device Record Status

Public Device Record Key

b3856f37-8938-4231-86ec-12a9fcef2b19

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

June 15, 2016

Additional Identifiers

Package DI Number

10818566010206

Quantity per Package

80

Contains DI Package

00818566010209

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"SVS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 486
2 A medical device with a moderate to high risk that requires special controls. 177
U Unclassified 1