Catalog Number

-

Brand Name

GOMCO CIRCUMCISION CLAMP

Version/Model Number

540-394B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 22, 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

K040052

Product Code

HFX

Product Code Name

Clamp, Circumcision

Public Device Record Key

a880bb8c-9ad3-4fe0-9308-78a7f19138cd

Public Version Date

September 24, 2018

Public Version Number

5

DI Record Publish Date

August 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-