DEVICE: LITHOCLAST (07613353204648)
Device Identifier (DI) Information
LITHOCLAST
B
In Commercial Distribution
FR-142#B/001
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution
FR-142#B/001
E.M.S. Electro Medical Systems S.A.
Vario Ultrasound handpiece Set
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? |
---|---|---|---|---|
37138 | Ultrasonic lithotripsy system handpiece |
A hand-held ultrasonic device that creates a high frequency vibration through a transducer, when electrical energy is applied to its piezo-ceramic elements, which is transmitted to stones (calculi) via a coaxially attached metal probe, fragmenting the stones. The electrical energy is supplied and regulated by an ultrasonic lithotripsy generator. The stone fragments are removed through the lumen of the probe and transducer by a suction system which is facilitated through the ultrasonic lithotripsy system. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FFK | Lithotriptor, Electro-Hydraulic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K012445 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
3036adf8-8a4e-4e79-b6eb-74ab32d6667b
September 22, 2021
1
September 14, 2021
September 22, 2021
1
September 14, 2021
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)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+41229944700
udi@ems-ch.com
udi@ems-ch.com