Catalog Number

VS0225

Brand Name

NANO SubRet Gateway Device

Version/Model Number

VS0225

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

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

HMX

Product Code Name

Cannula, Ophthalmic

Public Device Record Key

8c907c5f-9b6f-4e76-ba3a-d8e7a37b2b2c

Public Version Date

January 31, 2020

Public Version Number

1

DI Record Publish Date

January 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-