AESCULAP - BIPOLAR CABLE VALLEYLAB/AAG HEXAGONAL5 - Aesculap AG

Duns Number:315018218

Device Description: BIPOLAR CABLE VALLEYLAB/AAG HEXAGONAL5

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More Product Details

Catalog Number

GN080

Brand Name

AESCULAP

Version/Model Number

GN080

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 28, 2016

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

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Record Status

Public Device Record Key

aaa8f161-b2dc-496f-8ec0-02a8f94aa250

Public Version Date

June 19, 2020

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AESCULAP AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11840
2 A medical device with a moderate to high risk that requires special controls. 7088
3 A medical device with high risk that requires premarket approval 37