Catalog Number

-

Brand Name

AngioSystems Sharp Cup

Version/Model Number

1036

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K843260,K843260

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

6c99adb1-f6b7-4a24-862e-978ec9657eea

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 15, 2016

Package DI Number

00816611020050

Quantity per Package

12

Contains DI Package

00816611020029

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-