Surgical Probe, Monopolar w/Protected Plug - WR MEDICAL ELECTRONICS CO INC

Duns Number:006196604

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More Product Details

Catalog Number

-

Brand Name

Surgical Probe, Monopolar w/Protected Plug

Version/Model Number

3188

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

ETN

Product Code Name

Stimulator, Nerve

Device Record Status

Public Device Record Key

bac77943-cc5a-4d84-a9dc-86f26f32a618

Public Version Date

September 20, 2021

Public Version Number

3

DI Record Publish Date

August 29, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WR MEDICAL ELECTRONICS CO INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 13