Catalog Number

-

Brand Name

Post Medical, Inc.

Version/Model Number

1G

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"

-

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

K925816,K925816

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

020e97e8-5336-4588-b8dd-c3df92c3e6b7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 25, 2016

Package DI Number

B3091G1

Quantity per Package

16

Contains DI Package

B3091G0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case