NA - 20:1 Contra Angle Handpiece (low torque) - BICON, LLC

Duns Number:945015758

Device Description: 20:1 Contra Angle Handpiece (low torque)

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More Product Details

Catalog Number

260-028-202

Brand Name

NA

Version/Model Number

260-028-202

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

K020137

Product Code Details

Product Code

EGS

Product Code Name

Handpiece, Contra- And Right-Angle Attachment, Dental

Device Record Status

Public Device Record Key

2373a214-82ee-436f-82ec-d2b19a397779

Public Version Date

March 24, 2020

Public Version Number

6

DI Record Publish Date

November 01, 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