#111 Electrode - ELECTRODE 1/4"&3/8" REG WIRE 1/16" SHAFT - Ellman International

Duns Number:079095245

Device Description: ELECTRODE 1/4"&3/8" REG WIRE 1/16" SHAFT

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More Product Details

Catalog Number

T111B

Brand Name

#111 Electrode

Version/Model Number

T111B

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

-

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 Details

Product Code

JOS

Product Code Name

Electrode, electrosurgical

Device Record Status

Public Device Record Key

b59a6397-cd34-45de-b73a-93fc08184dc9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ELLMAN INTERNATIONAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 128