DEVICE: LITHOCLAST (07613353151843)

Device Identifier (DI) Information

LITHOCLAST
B
In Commercial Distribution
FR-089#A/001
E.M.S. Electro Medical Systems S.A.
07613353151843
GS1

1
481233849 *Terms of Use
Pneumatic handpiece pn3 kit
CLOSE

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?
47098 Pneumatic lithotripsy system handpiece
A hand-held component of a pneumatic intracorporeal lithotripsy system designed to hold the system's ballistic probe (i.e., it forms a handle around the probe) and is connected via a dedicated cable to the system's control unit from which energy is transmitted. The handpiece includes connectors and is typically made of metal [e.g., stainless steel, aluminium (Al)] and plastic materials. It may also facilitate suction used for the removal of the fragmented calculi. This is a reusable device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FFK Lithotriptor, Electro-Hydraulic
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K963285 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

5f7e95b4-9c65-4e54-b13c-8e09a7ec4299
September 15, 2021
1
September 07, 2021
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+41229944700
udi@ems-ch.com
CLOSE