Catalog Number

790.70

Brand Name

Beurer

Version/Model Number

OT20

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LHD

Product Code Name

Device, Fertility Diagnostic, Proceptive

Public Device Record Key

80068185-11ad-4997-81b6-f22c363942da

Public Version Date

November 17, 2020

Public Version Number

4

DI Record Publish Date

December 09, 2019

Package DI Number

20850003500434

Quantity per Package

18

Contains DI Package

10850003500437

Package Discontinue Date

November 16, 2020

Package Status

Not in Commercial Distribution

Package Type

Case Pack