Strauss Diamond - Diamond Strauss Instruments Inc

Duns Number:045784021

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More Product Details

Catalog Number

-

Brand Name

Strauss Diamond

Version/Model Number

POLIW2D

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

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 Details

Product Code

EJR

Product Code Name

Agent, Polishing, Abrasive, Oral Cavity

Device Record Status

Public Device Record Key

7044e004-6b44-4ca6-9eb7-4d63170281b4

Public Version Date

October 25, 2022

Public Version Number

1

DI Record Publish Date

October 17, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIAMOND STRAUSS INSTRUMENTS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 407
2 A medical device with a moderate to high risk that requires special controls. 1