PowerStick - PowerStick 20ga x 8cm, Power Rated EPIV with MST - NEO MEDICAL INC.

Duns Number:015510540

Device Description: PowerStick 20ga x 8cm, Power Rated EPIV with MST

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


More Product Details

Catalog Number

30101-1608

Brand Name

PowerStick

Version/Model Number

30101-1608

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Conditional

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

K071875,K071875

Product Code Details

Product Code

LJS

Product Code Name

Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

Device Record Status

Public Device Record Key

b404562f-b47f-4258-bd0f-1f609659ec12

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

B3393010116085

Quantity per Package

10

Contains DI Package

B3393010116080

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"NEO MEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 88