DEVICE: MECHANICAL LITHOTRIPTOR (04953170033001)

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Device Identifier (DI) Information

MECHANICAL LITHOTRIPTOR
BML-110A-1

OLYMPUS MEDICAL SYSTEMS CORP.
04953170033001
GS1
1
BML-110A-1 EMERGENCY LITHOTRIPTOR HANDLE
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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
Lithotrite A hand-held manual surgical instrument designed for the mechanical crushing of renal stones (calculi) in the urinary tract and/or bladder. It is typically designed with a sturdy pair of jaws at the distal end that are placed over and crush the stone when the operator applies pressure to the handles at the proximal end; the jaws close, grasp and crush the stone. Some types may employ a screw spindle which the operator can rotate to augment the crushing force. The instrument may be used endoscopically and may include a port for irrigation to provide a clear visual field. This device reflects old technology. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
LQC Lithotriptor, biliary mechanical
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Sterilization

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

In Commercial Distribution
September 21, 2016

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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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Yes
No
No
Yes
No CLOSE

Customer Contact

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+1(800)401-1086
xx@xx.xx
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