Catalog Number

-

Brand Name

TERUMO

Version/Model Number

SS+05L1U

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K023271,K023271,K023271

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

5df0e0ff-4486-45aa-973a-deaa28637c81

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

February 28, 2017

Package DI Number

34806017512881

Quantity per Package

100

Contains DI Package

14806017512887

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelfbox