DEVICE: LITHOCLAST (07613353125912)
Device Identifier (DI) Information
LITHOCLAST
A
In Commercial Distribution
DW-047B
E.M.S. Electro Medical Systems S.A.
A
In Commercial Distribution
DW-047B
E.M.S. Electro Medical Systems S.A.
Cart for Swiss LithoClast Trilogy
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? |
---|---|---|---|---|
40596 | Electromechanical device/system transport trolley |
A mobile (on wheels) cart intended to be used as a carrier for transporting an electromechanical device(s) or a powered system assembly. This trolley (cart) may be designed specifically for a proprietary control unit/system, and will typically have one or more horizontal surfaces where the devices are placed; it may include additional features (e.g., gas cylinder holder, intravenous pole) specific to a proprietary system. Neither electromechanical devices nor system components are included.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FEO | Lithotriptor, Ultrasonic |
FFK | Lithotriptor, Electro-Hydraulic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Weight: 23.50 Kilogram |
Device Record Status
9123c1bb-0031-491c-9e3f-249e72d85e28
November 25, 2019
1
November 15, 2019
November 25, 2019
1
November 15, 2019
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