AccessGUDID - DEVICE: Piezomed SA-320 1.8m (J021300780001)

GUDID

Device Identifier (DI) Information

Brand Name: Piezomed SA-320 1.8m
Version or Model: 30078000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: W & H Dentalwerk Bürmoos GmbH

Primary DI Number: J021300780001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 300238441 *Terms of Use

Device Description: Piezoelectric ultrasonic 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?
47010	Dental ultrasonic surgical system	An assembly of devices that converts high frequency current into ultrasonic oscillation to mechanically fragment and cut bone upon contact with a vibrating tip during dental surgery, typically in combination with irrigation. It typically includes an energy-producing generator with monitoring functions, a handpiece(s) with tip(s) to convert and apply the energy, connecting cables, and a foot-switch to regulate the energy. It is used for implant-site preparation, dental extraction, distraction, sinus lift, periodontal surgery, cyst removal, extraction of bone block, bone harvesting, osteoplasty and osteotomy.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZI	Drill, Bone, 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 35 Degrees Celsius
Storage Environment Humidity: between 8 and 80 Percent (%) Relative Humidity
Handling Environment Humidity: between 8 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a8f4ca2d-375c-4f89-81f4-caeb0189b8ec
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 19, 2016