Diamond file A1 - OSADA ELECTRIC CO.,LTD.

Duns Number:690713813

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More Product Details

Catalog Number

46049

Brand Name

Diamond file A1

Version/Model Number

Diamond file A1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K844250

Product Code Details

Product Code

ELC

Product Code Name

Scaler, ultrasonic

Device Record Status

Public Device Record Key

9701ed3f-4508-4459-ab3d-80e282c7e1b4

Public Version Date

February 21, 2019

Public Version Number

4

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OSADA ELECTRIC CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 56
2 A medical device with a moderate to high risk that requires special controls. 108
U Unclassified 8