Catalog Number

-

Brand Name

Benesta Single-Use Seals

Version/Model Number

CAL-1421

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

HIH

Product Code Name

Hysteroscope (And Accessories)

Public Device Record Key

3ea50e10-ef6c-4a84-a94f-a5c2325bbdf8

Public Version Date

July 26, 2022

Public Version Number

1

DI Record Publish Date

July 18, 2022

Package DI Number

00857492008072

Quantity per Package

10

Contains DI Package

00857492008126

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box