AtriCure System Cart - Basic Cart - ATRICURE, INC.

Duns Number:006133784

Device Description: Basic Cart

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More Product Details

Catalog Number

A000842

Brand Name

AtriCure System Cart

Version/Model Number

ASCB2

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)

-

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

HMF

Product Code Name

Stand, Instrument, Ac-Powered, Ophthalmic

Device Record Status

Public Device Record Key

8bdb88da-072a-4292-a27f-70e3e80becd8

Public Version Date

January 19, 2021

Public Version Number

1

DI Record Publish Date

January 11, 2021

Additional Identifiers

Package DI Number

30840143903438

Quantity per Package

1

Contains DI Package

10840143901522

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"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