Catalog Number

-

Brand Name

TERUMO

Version/Model Number

SS+30L1

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

K063613,K063613,K063613

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

2c8bbba3-e4df-4b34-a8bd-29c4d3da1c03

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

January 27, 2017

Package DI Number

54806017509434

Quantity per Package

8

Contains DI Package

34806017509430

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton