Catalog Number

205108

Brand Name

Extended Tip Applicator

Version/Model Number

205108

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

-

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

e70d6e16-d9ae-4aa9-8e96-4dd8ae7b2e0e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 29, 2016

Package DI Number

10884521056350

Quantity per Package

5

Contains DI Package

20884521056357

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE