Catalog Number

52000055

Brand Name

Devon

Version/Model Number

52000055

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

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

K040052,K040052

Product Code

HFX

Product Code Name

CLAMP, CIRCUMCISION

Public Device Record Key

2a850e18-0f4e-43a1-9bc5-bdf646c7aad8

Public Version Date

February 15, 2019

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

10884521157163

Quantity per Package

30

Contains DI Package

20884521157160

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE