Catalog Number

DF22G70MM21G

Brand Name

Eclipse DermaFlex MicroCannula

Version/Model Number

DF22G70MM21G

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

K200017,K200017

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

07e4ae70-d972-4c2b-a90c-89383cd4c5d7

Public Version Date

March 31, 2021

Public Version Number

1

DI Record Publish Date

March 23, 2021

Package DI Number

00853602008536

Quantity per Package

25

Contains DI Package

00853602008468

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box