Catalog Number

-

Brand Name

Syringe, Piston

Version/Model Number

18B-B

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

K092986,K092986

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

676abdf0-2c33-4db0-948e-f61954c65893

Public Version Date

April 08, 2019

Public Version Number

4

DI Record Publish Date

May 23, 2016

Package DI Number

10816513020131

Quantity per Package

500

Contains DI Package

00816513020134

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX