Catalog Number

RIIDSMMIC

Brand Name

Delfin

Version/Model Number

RIIDSMMIC

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

EFA

Product Code Name

Handpiece, Belt And/Or Gear Driven, Dental

Public Device Record Key

60c71cb3-549f-4143-981e-278e1c85428e

Public Version Date

July 19, 2019

Public Version Number

1

DI Record Publish Date

July 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-