Catalog Number

-

Brand Name

APmedical

Version/Model Number

FGPBS12R001 PBS 12R

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K071517

Product Code

MMK

Product Code Name

Container, Sharps

Public Device Record Key

cca9f00a-d7a7-4bfe-8987-23fb98711338

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-