Catalog Number

-

Brand Name

Orbit Subretinal Delivery System

Version/Model Number

PN1007138

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K182274

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

5c73e1f9-2262-4b07-ade7-ead219b610c8

Public Version Date

October 06, 2020

Public Version Number

3

DI Record Publish Date

April 30, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-