Catalog Number

-

Brand Name

ZIPSER PENIS CLAMP

Version/Model Number

540-380

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

-

Product Code

HFX

Product Code Name

Clamp, Circumcision

Public Device Record Key

56d1e5f8-0fea-4672-bb69-f33b451a9fbc

Public Version Date

November 11, 2019

Public Version Number

6

DI Record Publish Date

October 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-