Catalog Number

-

Brand Name

NAMIC

Version/Model Number

70127401

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K140194,K140194

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

b5bd79f1-a86f-438b-b9ea-daeb064311d5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

H965701274011

Quantity per Package

25

Contains DI Package

H965701274010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX