VERITAS SWIVEL PHACO HANDPIECE SYSTEM - VERITAS SWIVEL PHACO HANDPIECE SYSTEM - JOHNSON & JOHNSON SURGICAL VISION, INC.

Duns Number:103021940

Device Description: VERITAS SWIVEL PHACO HANDPIECE SYSTEM

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More Product Details

Catalog Number

VRT691027

Brand Name

VERITAS SWIVEL PHACO HANDPIECE SYSTEM

Version/Model Number

VRT691027

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

HQC

Product Code Name

Unit, phacofragmentation

Device Record Status

Public Device Record Key

d080c655-5c45-46ba-acef-a66456d3af30

Public Version Date

April 26, 2021

Public Version Number

1

DI Record Publish Date

April 16, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"JOHNSON & JOHNSON SURGICAL VISION, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 42
2 A medical device with a moderate to high risk that requires special controls. 77
3 A medical device with high risk that requires premarket approval 3950