Catalog Number

OP0918-111

Brand Name

V. Mueller

Version/Model Number

OP0918-111

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 01, 2018

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

HRH

Product Code Name

Trephine, manual, ophthalmic

Public Device Record Key

82cdde7e-a911-41b0-b67a-55ee752ce23c

Public Version Date

April 09, 2019

Public Version Number

2

DI Record Publish Date

September 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-