COMPLETE - COMPLETE MPS 120 ML + LENS CASE (LCA) - JOHNSON & JOHNSON SURGICAL VISION, INC.

Duns Number:103021940

Device Description: COMPLETE MPS 120 ML + LENS CASE (LCA)

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More Product Details

Catalog Number

93506LCAHZ

Brand Name

COMPLETE

Version/Model Number

93506LCAHZ

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LPN

Product Code Name

Accessories, soft lens products

Device Record Status

Public Device Record Key

d1dfa420-fa38-4955-b7ca-7c37424599eb

Public Version Date

February 26, 2020

Public Version Number

4

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

10827444000635

Quantity per Package

4

Contains DI Package

00827444000638

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"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