Catalog Number

MDS522320AC

Brand Name

Medline

Version/Model Number

MDS522320AC

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"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K925114

Product Code

HFI

Product Code Name

COAGULATOR, CULDOSCOPIC (AND ACCESSORIES)

Public Device Record Key

5ca13afd-3701-420d-804f-eb8eda6b4ecd

Public Version Date

August 21, 2019

Public Version Number

4

DI Record Publish Date

October 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-