Catalog Number

4004-15

Brand Name

SCANLAN® Miscellaneous Instruments

Version/Model Number

4004-15

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

GEN

Product Code Name

Forceps, General & Plastic Surgery

Public Device Record Key

9e174052-6f0e-4fae-a488-45f5a5b68beb

Public Version Date

November 28, 2019

Public Version Number

1

DI Record Publish Date

November 20, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-