AccessGUDID - DEVICE: KaVo Spray AMERICA 2113 (EKAV041196500)

GUDID

Device Identifier (DI) Information

Brand Name: KaVo Spray AMERICA 2113
Version or Model: 0.411.9650
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AMERICA 2113
Company Name: KaVo Dental GmbH

Primary DI Number: EKAV041196500
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 333710619 *Terms of Use

Device Description: This is a medical device.

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?
15772	Surgical instrument maintenance lubricant	A non-sterile solution intended to be applied to a surgical instrument prior to sterilization for purposes of lubrication/maintenance (e.g., to prevent moving or mating parts from sticking together during use, inhibit corrosion, and to improve longevity of the instrument); it is not dedicated to a particular type of surgical instrument. It may be a water-soluble solution, commonly known as instrument milk because of its white colour when mixed with water, in which the instrument is immersed, or it may be a spray that is sprayed onto the instrument. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFB	HANDPIECE, AIR-POWERED, DENTAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 -20 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 63e4d665-a968-465a-ae8f-281538edf9b0
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: September 26, 2016