Catalog Number

10-3880

Brand Name

SCHPENS FORKED ORBIATAL RETRACTOR

Version/Model Number

10-3880

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

-

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

HNI

Product Code Name

Retractor, ophthalmic

Public Device Record Key

a1ce013a-4b8f-4d92-abf2-9cefee52bfce

Public Version Date

October 22, 2018

Public Version Number

1

DI Record Publish Date

September 19, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-