LiV™ Instruments - LiV Colvin Needle Driver Curved, Short - ATRICURE, INC.

Duns Number:006133784

Device Description: LiV Colvin Needle Driver Curved, Short

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More Product Details

Catalog Number

N/A

Brand Name

LiV™ Instruments

Version/Model Number

001-340-7803S

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

-

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

DWS

Product Code Name

Instruments, Surgical, Cardiovascular

Device Record Status

Public Device Record Key

b7f8fac0-29a0-4d17-a104-3cad0d11c348

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

September 20, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ATRICURE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 129
2 A medical device with a moderate to high risk that requires special controls. 133
3 A medical device with high risk that requires premarket approval 11