Catalog Number

H9389BTS

Brand Name

NA

Version/Model Number

H9389BTS

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

K872743,K872743

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

cecc16fa-476b-4776-be7d-39775e58bb2e

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

50085412481406

Quantity per Package

10

Contains DI Package

00085412481401

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE