AccessGUDID - DEVICE: SonoBokk Series Diagnostic Ultrasound Systems (06945121412117)

GUDID

Device Identifier (DI) Information

Brand Name: SonoBokk Series Diagnostic Ultrasound Systems
Version or Model: SonoBook 6
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CHISON Medical Technologies Co., Ltd.

Primary DI Number: 06945121412117
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544914187 *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:	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?
40761	General-purpose ultrasound imaging system	A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170374	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: 82ca76d1-0e5f-448d-bf76-976e04a288f7
Public Version Date: September 05, 2022
Public Version Number: 5
DI Record Publish Date: November 22, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status
06945121412230	1	06945121412117	In Commercial Distribution
06945121412223	1	06945121412117	In Commercial Distribution
06945121412216	1	06945121412117	In Commercial Distribution
06945121412209	1	06945121412117	In Commercial Distribution
06945121412193	1	06945121412117	In Commercial Distribution
06945121412186	1	06945121412117	In Commercial Distribution
06945121412179	1	06945121412117	In Commercial Distribution
06945121412162	1	06945121412117	In Commercial Distribution
06945121412155	1	06945121412117	In Commercial Distribution
06945121412148	1	06945121412117	In Commercial Distribution