EVA NEXUS™ Irrigation and Aux. Aspiration Tubing - D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Duns Number:407522184

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More Product Details

Catalog Number

-

Brand Name

EVA NEXUS™ Irrigation and Aux. Aspiration Tubing

Version/Model Number

9110.IAD01

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

K213467,K213467

Product Code Details

Product Code

HQC

Product Code Name

Unit, Phacofragmentation

Device Record Status

Public Device Record Key

8ea66d35-9a38-46b0-b10c-a78892f6f83a

Public Version Date

July 11, 2022

Public Version Number

1

DI Record Publish Date

July 01, 2022

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