AccessGUDID - DEVICE: Nupro (D00390741L031)

GUDID

Device Identifier (DI) Information

Brand Name: Nupro
Version or Model: 90741L03
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dentsply Professional

Primary DI Number: D00390741L031
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 144140845 *Terms of Use

Device Description: Nupro Freedom™ with SmartMode™ Technology Cordless Prophy System Premium Kit - Lavender. Contains: 1 Cordless Prophy System, 3 Handpiece Sheaths, 200 Nupro Freedom® Disposable Prophy Angles, 500 Disposa-Shield® Barrier Trial Pack (Polyethylene Barriers)

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?
33878	Cable/lead/sensor/probe cover, non-sterile	A non-sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier to protect the contents from soiling and contamination so that the non-sterile contents may be used in the vicinity of, or enter into a hygienic area, e.g., a sterile surgical field. This is a single-use device.	Obsolete	false
46938	Dental polishing cup, single-use	A rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PEM	Dental barriers and sleeves
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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 50 Degrees Celsius
Storage Environment Humidity: between 45 and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify: Atmospheric limitations 50 to 106 kPa.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0cb4c1b9-a190-47d6-942b-10dd9547cd2b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: January 31, 2017