AccessGUDID - DEVICE: SonaStar (00841626101852)

GUDID

Device Identifier (DI) Information

Brand Name: SonaStar
Version or Model: SYSTEM-M380-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MISONIX, INC.

Primary DI Number: 00841626101852
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 065963449 *Terms of Use

Device Description: SonaStar FS 1000 RF Ultrasonic Surgical Aspiration System (240 V)

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":	Yes
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?
36273	Ultrasonic surgical system generator	An electrically-powered component of an ultrasonic surgical system intended to generate a high frequency electrical current that is converted, typically within a handpiece, into an ultrasonic oscillation to fragment hard and/or soft tissue cells upon contact with a vibrating tip. It is used in a variety of surgical disciplines (e.g., arthroscopy, gynaecology, neurosurgery, dental/craniomaxillofacial reconstructive surgery); it is not dedicated to dental applications. It provides the controls and monitoring functions for the system during the procedure, and typically regulates energy to the system via a foot-switch; integrated suction/aspiration function may be included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories
LFL	Instrument, Ultrasonic Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062471	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 81864145-d888-4f0e-9e93-3dcfea8721ae
Public Version Date: September 24, 2018
Public Version Number: 4
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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