ACTU8 Pro-Grip Forceps - ACTU8 Pro-Grip Forceps - VORTEX SURGICAL, LLC

Duns Number:080375891

Device Description: ACTU8 Pro-Grip Forceps

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More Product Details

Catalog Number

VS0713.23

Brand Name

ACTU8 Pro-Grip Forceps

Version/Model Number

Pro-Grip

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

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

HNR

Product Code Name

Forceps, Ophthalmic

Device Record Status

Public Device Record Key

0ca1d425-07f4-4dab-b5e4-cf6f93974535

Public Version Date

July 12, 2019

Public Version Number

2

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

-

"VORTEX SURGICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 28
2 A medical device with a moderate to high risk that requires special controls. 23