USA Universal Cataract Inst Set - BLINK MEDICAL LIMITED

Duns Number:738288096

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More Product Details

Catalog Number

-

Brand Name

USA Universal Cataract Inst Set

Version/Model Number

76-0026A

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)

-

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

c2d18693-b3c4-4a95-8890-ff980e77e677

Public Version Date

August 09, 2022

Public Version Number

1

DI Record Publish Date

August 01, 2022

Additional Identifiers

Package DI Number

05060745555857

Quantity per Package

10

Contains DI Package

05060745555840

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"BLINK MEDICAL LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 12