Catalog Number

-

Brand Name

APOTECA

Version/Model Number

ASN-03

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

K132011

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

79952ea5-1e92-4e87-a8a9-95f3c3eead99

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-