AccessGUDID - DEVICE: CanalPro (D661H8CPCLINTRO0)

GUDID

Device Identifier (DI) Information

Brand Name: CanalPro
Version or Model: H8CPCLINTRO
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: COLTENE/WHALEDENT INC

Primary DI Number: D661H8CPCLINTRO0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 622185718 *Terms of Use

Device Description: CanalPro CL Intro Kit

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63498	Dental power tool system handpiece, battery-powered	A hand-held, electrically-powered dental device that includes a chuck or collet for attaching a rotary dental endpiece (e.g., polishing brush) intended to be used in dental procedures, typically for cleaning and polishing teeth. It is a battery-powered cordless instrument with an integral electric motor and push buttons for controlling the device settings; the endpiece(s) is not included. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EKX	Handpiece, Direct Drive, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K990682	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Atmospheric Pressure: between .5 and 1.06 KiloPascal
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 50 Degrees Celsius
Handling Environment Atmospheric Pressure: between .5 and 1.06 KiloPascal
Handling Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between -10 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d49f076b-6be8-4d55-954e-f214b2dca39a
Public Version Date: March 11, 2019
Public Version Number: 1
DI Record Publish Date: February 11, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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