Catalog Number

SIEXC74-75Z

Brand Name

Swede Dental

Version/Model Number

SIEXC74-75Z

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EKC

Product Code Name

EXCAVATOR, DENTAL, OPERATIVE

Public Device Record Key

0a8c0c78-f22a-4a5c-badd-dc603a5db1fd

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 23, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-