Catalog Number

-

Brand Name

Procedure Products Syringe

Version/Model Number

4930-W

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,K884985

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

8a10a7fa-8aaa-483f-9b49-a72716f06e91

Public Version Date

September 12, 2018

Public Version Number

4

DI Record Publish Date

September 12, 2017

Package DI Number

B1604930W2

Quantity per Package

25

Contains DI Package

B1604930W1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box