Catalog Number

205115

Brand Name

Extended Tip Applicator

Version/Model Number

205115

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

d2c0dd21-9044-4660-84a6-f0b3477796f4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 29, 2016

Package DI Number

10884521056367

Quantity per Package

5

Contains DI Package

20884521056364

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE