NEUTRAL PAD - NEUTRAL PAD, SMALL DISPOSABLE, (25PCS) - Ellman International

Duns Number:079095245

Device Description: NEUTRAL PAD, SMALL DISPOSABLE, (25PCS)

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More Product Details

Catalog Number

IEC-NPD-S

Brand Name

NEUTRAL PAD

Version/Model Number

IEC-NPD-S

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)

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

ODR

Product Code Name

Electrosurgical patient return electrode

Device Record Status

Public Device Record Key

7c682b4b-a426-4a64-9602-8331aa35b522

Public Version Date

February 07, 2019

Public Version Number

3

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