PKS LP Scissors 5mm/33cm - Gyrus Acmi, Inc.

Duns Number:007198742

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

PKS LP Scissors 5mm/33cm

Version/Model Number

3804PK

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

34f49396-5283-463b-87e6-2aab91de636b

Public Version Date

August 03, 2022

Public Version Number

5

DI Record Publish Date

October 12, 2016

Additional Identifiers

Package DI Number

00821925010765

Quantity per Package

5

Contains DI Package

00821925038011

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