Catalog Number

52000081

Brand Name

Devon

Version/Model Number

52000081

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

Yes

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

d04e87b2-3d76-4f50-8390-3c75670f0453

Public Version Date

February 15, 2019

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

10884527007042

Quantity per Package

20

Contains DI Package

20884527007049

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE