Catalog Number

60029885

Brand Name

MicroMega One RECI

Version/Model Number

N25 6% L25 STERILE

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

-

Product Code

EKS

Product Code Name

File, Pulp Canal, Endodontic

Public Device Record Key

ccf0462c-b7c7-4313-bb48-829846cf80f7

Public Version Date

September 29, 2022

Public Version Number

1

DI Record Publish Date

September 21, 2022

Package DI Number

J015600298859

Quantity per Package

10

Contains DI Package

J015600298851

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-