Catalog Number

WAL306

Brand Name

WALTERLORENZ™ SURGICAL ASSIST ARM

Version/Model Number

WAL306

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

-

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

GDG

Product Code Name

HOOK, SURGICAL, GENERAL & PLASTIC SURGERY

Public Device Record Key

51096352-987b-4d9d-b282-4223a049c207

Public Version Date

September 22, 2020

Public Version Number

2

DI Record Publish Date

June 17, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-