AccessGUDID - DEVICE: Sonicure (16972304750473)

GUDID

Device Identifier (DI) Information

Brand Name: Sonicure
Version or Model: SC35C+
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

Primary DI Number: 16972304750473
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 550274579 *Terms of Use

Device Description: No description.

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:	Yes
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?
44778	Soft-tissue ultrasonic surgical system	An assembly of devices that converts high frequency current into ultrasonic oscillation to mechanically fragment soft-tissue cells upon contact with a vibrating tip for cutting and/or coagulating tissue during surgery, possibly in combination with irrigation and aspiration. Ongoing vibration may create heat in cells (diathermy) to increase the cutting/coagulating capacity. It typically includes an energy-producing generator with monitoring functions, a handpiece(s) with tip(s) to convert and apply the energy, connecting cables, a foot-switch as an option to regulate the energy, and possibly an integrated irrigation/suction system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LFL	Instrument, Ultrasonic Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212614	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: fa1144ee-88b9-443d-8e05-cf53e8a26fc0
Public Version Date: November 03, 2022
Public Version Number: 1
DI Record Publish Date: October 26, 2022