Catalog Number

305559

Brand Name

BD Safety-Lok

Version/Model Number

305559

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

K944757,K944757,K944757

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

ef0d2178-7933-4fd8-b91f-bf95ec7ac38a

Public Version Date

September 12, 2018

Public Version Number

4

DI Record Publish Date

September 19, 2016

Package DI Number

50382903055598

Quantity per Package

8

Contains DI Package

30382903055594

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case