Catalog Number

11.46.25PIN

Brand Name

Synergetics

Version/Model Number

11.46.25PIN

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

-

Product Code

HNR

Product Code Name

Forceps, ophthalmic

Public Device Record Key

e72f39ff-2669-4dff-bd93-531531d49f3a

Public Version Date

October 23, 2019

Public Version Number

1

DI Record Publish Date

October 15, 2019

Package DI Number

20841305112098

Quantity per Package

5

Contains DI Package

10841305112084

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box