Catalog Number

31160156

Brand Name

Devon

Version/Model Number

31160156

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MDM

Product Code Name

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Public Device Record Key

4448db0d-8dd6-4588-ba90-9006b7a3bc62

Public Version Date

April 21, 2021

Public Version Number

5

DI Record Publish Date

June 23, 2018

Package DI Number

10884527011742

Quantity per Package

80

Contains DI Package

30884527011746

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE