Catalog Number

279351300RH

Brand Name

Medline

Version/Model Number

279351300RH

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

K172608

Product Code

NUJ

Product Code Name

Electrosurgical, cutting & coagulation accessories, laparoscopic & endoscopic, reprocessed

Public Device Record Key

5d98312e-2985-46d4-a63f-d38a6e62ebe4

Public Version Date

April 18, 2022

Public Version Number

1

DI Record Publish Date

April 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-