N/A - Retinal Cannula with Silicone Top, 23Ga. - MICROVISION, INC.

Duns Number:013486803

Device Description: Retinal Cannula with Silicone Top, 23Ga.

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More Product Details

Catalog Number

5161

Brand Name

N/A

Version/Model Number

N/A

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

HMX

Product Code Name

Cannula, Ophthalmic

Device Record Status

Public Device Record Key

93d730eb-b4e5-4313-9149-1df286fe24b8

Public Version Date

October 07, 2019

Public Version Number

6

DI Record Publish Date

April 04, 2018

Additional Identifiers

Package DI Number

30818255010634

Quantity per Package

5

Contains DI Package

10818255010630

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton

"MICROVISION, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14
2 A medical device with a moderate to high risk that requires special controls. 35