Catalog Number

SIS204SDXC

Brand Name

Swede Dental

Version/Model Number

SIS204SDXC

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

EMN

Product Code Name

SCALER, PERIODONTIC

Public Device Record Key

e1cfe7e7-e221-4f00-a131-ba6d16ac2ece

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

-