Catalog Number

P0013M

Brand Name

MEDLINE

Version/Model Number

P0013M

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"

Yes

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

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

c8babd12-df7a-4767-bd7b-ad056c8e1e77

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

April 13, 2020

Package DI Number

40888277754639

Quantity per Package

12

Contains DI Package

10888277754638

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE