Curette - Severe Bend Sinus Lift Currette - BICON, LLC

Duns Number:945015758

Device Description: Severe Bend Sinus Lift Currette

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More Product Details

Catalog Number

260-801-515

Brand Name

Curette

Version/Model Number

260-801-515

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)

Yes

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

DZN

Product Code Name

Instruments, Dental Hand

Device Record Status

Public Device Record Key

b411c4c3-af4f-4416-a5f7-3fc3dd61167a

Public Version Date

March 25, 2020

Public Version Number

4

DI Record Publish Date

June 10, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BICON, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 264
2 A medical device with a moderate to high risk that requires special controls. 421