Catalog Number

-

Brand Name

BELLOW WITH VENTIL AND CONNECTION

Version/Model Number

04-11020-10

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 20, 2018

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"

-

For Single-Use

-

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

K002877

Product Code

HET

Product Code Name

Laparoscope, Gynecologic (And Accessories)

Public Device Record Key

b281c18c-8db3-44b1-942f-55e613fe9556

Public Version Date

September 20, 2018

Public Version Number

5

DI Record Publish Date

September 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-