Catalog Number

-

Brand Name

Walcott Rx

Version/Model Number

RX30-1203

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

K913514,K913514,K913514

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

ac28aa49-36a3-4bf9-b88a-a81daa14d2c7

Public Version Date

July 11, 2022

Public Version Number

6

DI Record Publish Date

July 04, 2016

Package DI Number

20841019109988

Quantity per Package

50

Contains DI Package

00841019109984

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-