Catalog Number

-

Brand Name

5.5mm Operative Sheath

Version/Model Number

60-202

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K182006,K182006,K182006

Product Code

HIH

Product Code Name

HYSTEROSCOPE (AND ACCESSORIES)

Public Device Record Key

d609884e-5644-4146-9255-15a64e46129a

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

December 10, 2018

Package DI Number

25420045510347

Quantity per Package

1

Contains DI Package

15420045510272

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX