DEVICE: SonoScape (06945868680008)

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Device Record History
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Device Identifier (DI) Information
SonoScape
SSI-8000
In Commercial Distribution

SONOSCAPE MEDICAL CORP.
06945868680008
GS1

1
545342185 *Terms of Use
SSI-8000 Mobile Digital Color Doppler Ultrasound System
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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FDA Product Code

[?]
Product Code Product Code Name
IYO System, Imaging, Pulsed Echo, Ultrasonic
ITX Transducer, Ultrasonic, Diagnostic
IYN System, Imaging, Pulsed Doppler, Ultrasonic
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K102642 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
c263ef8d-a0b9-439f-8e1f-89635253547e
July 06, 2018
4
August 19, 2016
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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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