Everest BiCOAG LP Scissors 5mm/45cm - Gyrus Acmi, Inc.

Duns Number:007198742

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More Product Details

Catalog Number

-

Brand Name

Everest BiCOAG LP Scissors 5mm/45cm

Version/Model Number

3844

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 21, 2017

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

K031081,K031081

Product Code Details

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Record Status

Public Device Record Key

27fb04b7-a904-458b-9c00-aa8a63576f1b

Public Version Date

August 03, 2022

Public Version Number

5

DI Record Publish Date

October 03, 2016

Additional Identifiers

Package DI Number

00821925010758

Quantity per Package

5

Contains DI Package

00821925041622

Package Discontinue Date

March 21, 2017

Package Status

Not in Commercial Distribution

Package Type

-

"GYRUS ACMI, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 899
2 A medical device with a moderate to high risk that requires special controls. 1586
3 A medical device with high risk that requires premarket approval 9
U Unclassified 4