MICS 1.8 mm Reusable phaco set with 45° straight flared needle - D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Duns Number:407522184

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More Product Details

Catalog Number

3445.18SF1

Brand Name

MICS 1.8 mm Reusable phaco set with 45° straight flared needle

Version/Model Number

3445.18SF1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K190875,K190875

Product Code Details

Product Code

HQC

Product Code Name

Unit, Phacofragmentation

Device Record Status

Public Device Record Key

321ea508-cc1c-4e42-8e1a-eca7842b4336

Public Version Date

March 19, 2020

Public Version Number

2

DI Record Publish Date

February 10, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNATIONAL) B.V." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 203
2 A medical device with a moderate to high risk that requires special controls. 149