Catalog Number

STR-021621-00

Brand Name

Cannula

Version/Model Number

Standard

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 05, 2021

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K120098,K120098

Product Code

GZL

Product Code Name

Electrode, Depth

Public Device Record Key

bf56c1a2-1979-478d-8f06-e963b3722f0e

Public Version Date

April 06, 2021

Public Version Number

2

DI Record Publish Date

September 03, 2020

Package DI Number

17290114060407

Quantity per Package

10

Contains DI Package

07290114060400

Package Discontinue Date

April 05, 2021

Package Status

Not in Commercial Distribution

Package Type

Carton