Arthrex® - 4K LAPAROSCOPE, 0 DEG, 10 X 330MM - ARTHREX, INC.

Duns Number:131747628

Device Description: 4K LAPAROSCOPE, 0 DEG, 10 X 330MM

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


More Product Details

Catalog Number

AR-3351-1000

Brand Name

Arthrex®

Version/Model Number

AR-3351-1000

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

-

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

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Device Record Status

Public Device Record Key

8aa24a25-5a62-4235-a624-ca5d853efd50

Public Version Date

March 02, 2022

Public Version Number

24

DI Record Publish Date

February 15, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARTHREX, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6506
2 A medical device with a moderate to high risk that requires special controls. 3411
3 A medical device with high risk that requires premarket approval 1
U Unclassified 2