Catalog Number

-

Brand Name

Walcott Rx

Version/Model Number

RX14-5009

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

K864402,K864402,K864402

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

eb426be1-db60-4c90-94ba-2dcf9ab1fe0d

Public Version Date

July 11, 2022

Public Version Number

5

DI Record Publish Date

July 04, 2016

Package DI Number

20841019109919

Quantity per Package

50

Contains DI Package

00841019109915

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-