VitreQ - 23G Standard Light Fibers - Vitreq B.V.

Duns Number:491393613

Device Description: 23G Standard Light Fibers

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More Product Details

Catalog Number

-

Brand Name

VitreQ

Version/Model Number

LF23.D01

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

MPA

Product Code Name

Endoilluminator

Device Record Status

Public Device Record Key

6e503d99-5676-4762-9df2-1d7267353f1c

Public Version Date

May 20, 2019

Public Version Number

1

DI Record Publish Date

May 12, 2019

Additional Identifiers

Package DI Number

08719214222093

Quantity per Package

5

Contains DI Package

08719214222109

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"VITREQ B.V." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 81
2 A medical device with a moderate to high risk that requires special controls. 44