Catalog Number

4960-R

Brand Name

Procedure Products Syringe

Version/Model Number

4960-R

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K884985

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

4cffa4ef-0843-4314-aa3d-01b1cd8d146a

Public Version Date

January 14, 2019

Public Version Number

1

DI Record Publish Date

December 12, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-