HK Aspirator Pump 115V - HK Aspirator Pump 115V - HK SURGICAL INC.

Duns Number:106885259

Device Description: HK Aspirator Pump 115V

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More Product Details

Catalog Number

AP-III

Brand Name

HK Aspirator Pump 115V

Version/Model Number

AP-III

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 10, 2020

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K032802

Product Code Details

Product Code

MUU

Product Code Name

System, Suction, Lipoplasty

Device Record Status

Public Device Record Key

83b846cc-587d-473d-b683-002ad2d6036e

Public Version Date

August 11, 2020

Public Version Number

4

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HK SURGICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 77
2 A medical device with a moderate to high risk that requires special controls. 12