CanalPro - CL Contra-Angle Gear - COLTENE/WHALEDENT INC

Duns Number:622185718

Device Description: CL Contra-Angle Gear

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More Product Details

Catalog Number

-

Brand Name

CanalPro

Version/Model Number

60011041

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"

-

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

K990682

Product Code Details

Product Code

EKX

Product Code Name

Handpiece, Direct Drive, Ac-Powered

Device Record Status

Public Device Record Key

96f6b5f9-084a-47f9-8703-724cb5276a2f

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 26, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COLTENE/WHALEDENT INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 553
2 A medical device with a moderate to high risk that requires special controls. 248
U Unclassified 10