Catalog Number

-

Brand Name

AHS

Version/Model Number

AH10L

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

4b1e0332-f030-43b0-bca6-714415e9f5d3

Public Version Date

October 26, 2020

Public Version Number

5

DI Record Publish Date

March 31, 2016

Package DI Number

B031AH10L2

Quantity per Package

1500

Contains DI Package

B031AH10L1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton