Catalog Number

309661

Brand Name

BD Luer-Lok

Version/Model Number

309661

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K110771,K110771,K110771

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

7438167b-2814-481f-86ae-1f9b4613a80d

Public Version Date

October 01, 2018

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

50382903096614

Quantity per Package

4

Contains DI Package

30382903096610

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case