DEVICE: 75L38EA Ultrasonic Transducer(FDA) (06944904088754)
Device Identifier (DI) Information
75L38EA Ultrasonic Transducer(FDA)
PL1A-30-90971
In Commercial Distribution
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
PL1A-30-90971
In Commercial Distribution
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
No description.
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Extracorporeal ultrasound imaging transducer, hand-held | A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). 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 an ultrasound system controller for image processing and display. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ITX | Transducer, ultrasonic, diagnostic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K111435 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
886fc4d1-fc16-41d9-ab66-ce0ff390c456
July 06, 2018
4
September 23, 2016
July 06, 2018
4
September 23, 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 |
---|---|---|---|---|---|
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
[?]
+8675581888998
service@mindray.com.cn
service@mindray.com.cn