Catalog Number

OS08400

Brand Name

V. Mueller

Version/Model Number

OS08400

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

-

Product Code

EMF

Product Code Name

KNIFE, SURGICAL

Public Device Record Key

e76825e0-4cbf-464a-b9b6-2ef46af8aed0

Public Version Date

January 22, 2021

Public Version Number

3

DI Record Publish Date

September 07, 2018

Package DI Number

70885403128839

Quantity per Package

12

Contains DI Package

10885403128837

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack