AccessGUDID - DEVICE: Midmark (00841709110337)

GUDID

Device Identifier (DI) Information

Brand Name: Midmark
Version or Model: 153603LR-E
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 153603LR-E
Company Name: MIDMARK CORPORATION

Primary DI Number: 00841709110337
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005036025 *Terms of Use

Device Description: The Procenter LR Mounted (Elevance) Cuspidors are intended to provide water for oral rinsing, and a drain to dispose of waste water and oral debris during dental examinations.

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?
60930	Dental delivery system instrument unit, electric	A mains electricity (AC-powered) device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted. The device is commonly referred to as a dental unit or dental operative unit and is intended to be operated by a healthcare professional in a medical facility.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIA	Unit, operative dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K003090	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
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -5 and 38 Degrees Celsius
Storage Environment Temperature: between -5 and 38 Degrees Celsius
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f3de4628-c374-4436-a559-de9c1976d149
Public Version Date: June 01, 2020
Public Version Number: 1
DI Record Publish Date: May 22, 2020