Catalog Number

-

Brand Name

Simpli

Version/Model Number

74553

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K100812,K100812,K100812

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

ad6422c2-70e3-4238-a223-55c5513d27d4

Public Version Date

May 11, 2020

Public Version Number

1

DI Record Publish Date

May 01, 2020

Package DI Number

30357515745539

Quantity per Package

12

Contains DI Package

20357515745532

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case