Catalog Number

1285-01

Brand Name

Medovations®

Version/Model Number

1285-01

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

MDM

Product Code Name

Instrument, Manual, Surgical, General Use

Public Device Record Key

9c955fa3-1741-4e7a-9bb6-bcd46601c529

Public Version Date

April 20, 2020

Public Version Number

5

DI Record Publish Date

September 07, 2018

Package DI Number

M7831285011

Quantity per Package

50

Contains DI Package

M7831285010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case