DEVICE: AUTOCLAVABLE TRANSDUCER (04953170157134)

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Device Identifier (DI) Information

AUTOCLAVABLE TRANSDUCER
MAJ-1215

OLYMPUS MEDICAL SYSTEMS CORP.
04953170157134
GS1
1
MAJ-1215 AUTOCLAVABLE XDUCER FOR LUS-2
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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
Ultrasonic lithotripsy system transducer, reusable A catheter-enclosed device used as a component of an ultrasonic lithotripsy system to transform electrical energy into ultrasonic energy to deliver localized lithotripsy treatments (the breaking up of a stone or calculus). It is introduced into the body through vascular access, surgically, or endoscopically. This ultrasound transducer is composed of either a single transducer element or an array of transducer elements [i.e., piezoelectric or active element(s), or crystal(s) and associated damping, backing, and matching layer materials]. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
FEO Lithotriptor, ultrasonic
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
High-level Disinfectant
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)401-1086
xx@xx.xx
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