Fine Touch Aspiration Tubing - FINE TOUCH ASPIRATION TUBING - HK SURGICAL INC.

Duns Number:106885259

Device Description: FINE TOUCH ASPIRATION TUBING

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


More Product Details

Catalog Number

ATF-20

Brand Name

Fine Touch Aspiration Tubing

Version/Model Number

ATF-20

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 29, 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"

Yes

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

-

Product Code Details

Product Code

GAZ

Product Code Name

Tubing, Noninvasive

Device Record Status

Public Device Record Key

3f968c89-0d0c-42fb-9b6e-4b83e99b9e7c

Public Version Date

July 01, 2020

Public Version Number

2

DI Record Publish Date

May 31, 2020

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