Beaver-Visitec - Malosa Core LASIK Pack 2 (20/SP) - Beaver-Visitec International, Inc.

Duns Number:001406024

Device Description: Malosa Core LASIK Pack 2 (20/SP)

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More Product Details

Catalog Number

MMK100/2

Brand Name

Beaver-Visitec

Version/Model Number

MMK100/2

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

PZG

Product Code Name

Surgical Eye Tray

Device Record Status

Public Device Record Key

941438ee-7219-44be-af7a-266f4708301f

Public Version Date

November 23, 2021

Public Version Number

1

DI Record Publish Date

November 15, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BEAVER-VISITEC INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 441
2 A medical device with a moderate to high risk that requires special controls. 35
U Unclassified 34