Catalog Number

SWCGR

Brand Name

WedgeWands®

Version/Model Number

SWCGR

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

EJB

Product Code Name

Handle, Instrument, Dental

Public Device Record Key

6fdb3407-2737-4da7-9efc-a901d9c8ff8e

Public Version Date

May 04, 2020

Public Version Number

1

DI Record Publish Date

April 24, 2020

Package DI Number

20810038092885

Quantity per Package

3

Contains DI Package

10810038092888

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

WCGR