Catalog Number

08-4101

Brand Name

EndoSheath Technology

Version/Model Number

CF-2.1

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K071127,K071127

Product Code

HIH

Product Code Name

Hysteroscope (And Accessories)

Public Device Record Key

b35551ea-9cbb-4f4e-8734-4944e343e818

Public Version Date

November 10, 2021

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

20874485001319

Quantity per Package

10

Contains DI Package

00874485003142

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-