Catalog Number

-

Brand Name

Syringe w/Needle

Version/Model Number

7013

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"

-

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

K112057,K112057,K112057

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

52981a60-5a78-4abc-a364-1e8b081ffb2a

Public Version Date

October 23, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

00616784701332

Quantity per Package

4

Contains DI Package

00616784701325

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-