Acessa ProVu Handpiece - Disposable Handpiece connects to Acessa ProVu - ACESSA HEALTH INC.

Duns Number:080935394

Device Description: Disposable Handpiece connects to Acessa ProVu Console

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More Product Details

Catalog Number

-

Brand Name

Acessa ProVu Handpiece

Version/Model Number

7300

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

Yes

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

HFG

Product Code Name

Coagulator, Laparoscopic, Unipolar (And Accessories)

Device Record Status

Public Device Record Key

23dc610b-beba-4172-aee9-31913ccc3b16

Public Version Date

March 09, 2021

Public Version Number

3

DI Record Publish Date

October 11, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACESSA HEALTH INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 10