AccessGUDID - DEVICE: Sonon (00860000879842)

GUDID

Device Identifier (DI) Information

Brand Name: Sonon
Version or Model: 300L
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 300L
Company Name: Healcerion Co., Ltd.

Primary DI Number: 00860000879842
Issuing Agency: GS1
Commercial Distribution End Date: June 21, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 688732988 *Terms of Use

Device Description: System, Imaging, Pulsed Echo, Ultrasonic

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?
40767	Extracorporeal ultrasound imaging transducer, mounted	An ultrasound imaging transducer assembly that is either located within the housing of an ultrasound based scanner system, e.g., a breast scanning system, Doppler flow system, ultrasound based bone absorptiometry or densitometry system; or is mounted on a floor, wall or ceiling suspension allowing the operator to position the transducer assembly outside of the patient's body. Included is a variety of single or multiple element transducer assembly configurations that convert electric voltages into an ultrasound beam. It steers, focuses and detects the ultrasound beam and resulting echoes either mechanically or electronically. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYO	System, Imaging, Pulsed Echo, Ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170085	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: dac7093a-19ba-4052-a792-ef602c1bd871
Public Version Date: June 21, 2021
Public Version Number: 3
DI Record Publish Date: January 21, 2019

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 877-5726530
Email: tony@healcerionusa.com

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