Catalog Number

-

Brand Name

Coronet

Version/Model Number

53-953

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 29, 2019

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HNR

Product Code Name

Forceps, Ophthalmic

Public Device Record Key

fa19f5e0-6ad2-46b3-9aaa-3663a6e0dc78

Public Version Date

September 06, 2019

Public Version Number

1

DI Record Publish Date

August 29, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-