Catalog Number

-

Brand Name

Disposa-Filter Assy

Version/Model Number

54298

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K875084,K875084

Product Code

HHK

Product Code Name

CURETTE, SUCTION, ENDOMETRIAL (AND ACCESSORIES)

Public Device Record Key

97e0781f-ebde-4772-8922-a43d9c54a891

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 12, 2016

Package DI Number

00821925005341

Quantity per Package

10

Contains DI Package

00821925037663

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-