Catalog Number

-

Brand Name

SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ URO

Version/Model Number

C010012

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"

Yes

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

HET

Product Code Name

Laparoscope, Gynecologic (And Accessories)

Public Device Record Key

fbc70530-cc47-4b13-bf38-b5a3a822fd9d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 11, 2016

Package DI Number

M648C0100121

Quantity per Package

10

Contains DI Package

M648C0100120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag