Catalog Number

SD37957

Brand Name

Surgical Direct

Version/Model Number

SD37957

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

GEN

Product Code Name

Forceps, General & Plastic Surgery

Public Device Record Key

58057e2e-fc94-4bd6-b508-d124632d1f8a

Public Version Date

May 04, 2020

Public Version Number

1

DI Record Publish Date

April 25, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-