DEVICE: PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE (00810000980017)

Device Identifier (DI) Information

PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE
P3000002
In Commercial Distribution

UNITED MEDICAL SYSTEMS (DE), INC.
00810000980017
GS1

1
002329923 *Terms of Use
Extracorporeal Shockwave Lithotripsy System (ESWL) - ESWL Control Unit, Litho Arm for X-ray C-arm, X-ray C-arm, Ultrasound Device, Lithotripsy Table
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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?
18416 Piezoelectric lithotripsy system
An assembly of devices that non-invasively disintegrates stones (i.e., calculi) by sending focused shock waves from outside the body produced by a piezoelectric generator. This generator contains an array of up to 4,000 ceramic elements arranged on a spherical dish; shock waves are generated at the focal point of the dish when a short, high-voltage pulse is simultaneously applied to each element. This system also includes a treatment table, an imaging system, and an operator's console. This [extracorporeal shock wave lithotripsy (ESWL)] system is used to disintegrate stones located in the kidneys, urinary tract, gallbladder, or bile/pancreatic ducts.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LNS Lithotriptor, Extracorporeal Shock-Wave,Urological
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K072538 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

9b6a2a38-32bc-419a-bdad-dd3cec8db4be
October 29, 2018
1
September 28, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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6142988150
TAMLAND@AKSM.COM
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