AccessGUDID - DEVICE: KERR (10817417020043)

GUDID

Device Identifier (DI) Information

Brand Name: KERR
Version or Model: AEU-28KER
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AEU-28KER
Company Name: ASEPTICO, INC.

Primary DI Number: 10817417020043
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2032
Device Count: 1
Labeler D-U-N-S® Number*: 016853348 *Terms of Use

Device Description: HANDPIECE, DIRECT DRIVE, AC-POWERED (CONSOLE)

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:	Yes
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?
38347	Dental power tool system handpiece, line-powered	A hand-held, mains electricity (AC-powered) dental device that includes a chuck or collet for attaching a dental endpiece (e.g., drill bit, bur, reamer, saw blade, polishing disk) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. It is powered by a low-voltage electric micro-motor (e.g., 24 volt) that is an integral part of the device; the endpiece(s) are not included. It is typically connected through the dental delivery system or a freestanding independent control unit. 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 [?]
Premarket Submission Number Not Available/Not Released

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
Handling Environment Temperature: between 10 and 28 Degrees Celsius
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 69.7 and 101.33 KiloPascal
Storage Environment Atmospheric Pressure: between 69.7 and 101.33 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Weight: 8 Pound

Device Record Status

Public Device Record Key: 6b667931-46c2-4b60-882b-a54836b4bec5
Public Version Date: November 22, 2018
Public Version Number: 3
DI Record Publish Date: September 26, 2017

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

[?]

Phone: 425 487 3157
Email: info@aseptico.com

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