AccessGUDID - DEVICE: MIDWEST® (D00390702L011)

GUDID

Device Identifier (DI) Information

Brand Name: MIDWEST®
Version or Model: 90702L01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Dentsply Professional

Primary DI Number: D00390702L011
Issuing Agency: HIBCC
Commercial Distribution End Date: December 22, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 144140845 *Terms of Use

Device Description: MIDWEST® RDH Freedom® Cordless Prophy System, Premium System With Carrying Case - Lavender Contains: 3 Sheaths, 200 NUPRO Freedom® Disposable Prophy Angles and 1 Disposa-Shield ® Trial Pack.

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?
63978	Dental power tool non-rotary polishing endpiece	An oscillating, sagittal, or reciprocating dental instrument designed to be attached to a dedicated dental power tool handpiece to perform a specific final mechanical function (e.g., polishing, contouring, finishing) during an orthodontic procedure (e.g., interproximal reduction). It is a metallic flat endpiece in the form of a blade; some types may be diamond coated. This is a reusable device.	Active	false
66247	Dental power tool handpiece motorless component	A component of a dental power tool handpiece designed to connect between a dental power tool motor and an endpiece to transfer mechanical energy from the motor to the endpiece during a dental surgical procedure. It may be in the form of a torque multiplier, adapter, or motorless handpiece. Neither the motor nor the endpiece is included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKX	HANDPIECE, DIRECT DRIVE, AC-POWERED
PEM	Dental barriers and sleeves

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Atmospheric limitations 500 to 1060 hPa.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b7dfbf86-b3e5-449e-9b14-b2a68a1dc9c1
Public Version Date: February 08, 2023
Public Version Number: 3
DI Record Publish Date: January 31, 2017