DEVICE: EC9-4 Transducer (04056869005300)
Device Identifier (DI) Information
EC9-4 Transducer
08648029
In Commercial Distribution
SIEMENS MEDICAL SOLUTIONS USA, INC.
08648029
In Commercial Distribution
SIEMENS MEDICAL SOLUTIONS USA, INC.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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40771 | Rectal/vaginal ultrasound imaging transducer |
An invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to another device for display; it does not include an integrated display. It may be intended for wired or wireless data transfer and may be intended for use with a dedicated ultrasound system or with an off-the-shelf device (e.g., smartphone) with dedicated software installed. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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ITX | Transducer, ultrasonic, diagnostic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K121699 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
57caea32-3790-4722-9a95-b84841cc8f4c
November 18, 2021
5
September 24, 2016
November 18, 2021
5
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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)888-7436
CONTACT@SIEMENS-HEALTHINEERS.COM
CONTACT@SIEMENS-HEALTHINEERS.COM