TECNIS IOL - TEC SYMF TOR II OB SMPCY 18.5D CYL3.75 - JOHNSON & JOHNSON SURGICAL VISION, INC.

Duns Number:103021940

Device Description: TEC SYMF TOR II OB SMPCY 18.5D CYL3.75

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More Product Details

Catalog Number

DXW375U185

Brand Name

TECNIS IOL

Version/Model Number

DXW375

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

HQL

Product Code Name

intraocular lens

Device Record Status

Public Device Record Key

509c405c-81ec-41a9-a1d1-1390ff0570e6

Public Version Date

February 17, 2022

Public Version Number

1

DI Record Publish Date

February 09, 2022

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