Patient Return Pads - Patient Return Pads Dual Section Grounding Pads - Coopersurgical, Inc.

Duns Number:801895244

Device Description: Patient Return Pads Dual Section Grounding Pads

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More Product Details

Catalog Number

-

Brand Name

Patient Return Pads

Version/Model Number

72308

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"

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

-

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

529e481c-2af4-4588-8027-038a698ce66a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 03, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COOPERSURGICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 29
2 A medical device with a moderate to high risk that requires special controls. 1471
3 A medical device with high risk that requires premarket approval 2