LIQUID OPTICS INTERFACE - DAILY ALIGNMENT VERIF INTERFACE,GEN2 LOI - JOHNSON & JOHNSON SURGICAL VISION, INC.

Duns Number:010130626

Device Description: DAILY ALIGNMENT VERIF INTERFACE,GEN2 LOI

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More Product Details

Catalog Number

0180-2010

Brand Name

LIQUID OPTICS INTERFACE

Version/Model Number

0180-2010

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)

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

OOE

Product Code Name

Ophthalmic femtosecond laser

Device Record Status

Public Device Record Key

629f00b8-c285-49a2-a3b2-927029209e8e

Public Version Date

October 26, 2020

Public Version Number

4

DI Record Publish Date

June 08, 2018

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