DEVICE: Revolution 45MHz Rotational IVUS Imaging Catheter (00184360000358)

Device Identifier (DI) Information

Revolution 45MHz Rotational IVUS Imaging Catheter
89000
In Commercial Distribution

Volcarica S.R.L.
00184360000358
GS1

1
853202646 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Intravascular ultrasound imaging transducer, single-use A catheter-based ultrasound imaging transducer enclosed in a fluid resistant or waterproof acoustically and electrically insulated housing designed for insertion into the vascular system (i.e., vein or artery) and positioned by the operator. Also known as a vascular probe or transducer, it is frequently incorporated as part of, or used with, devices requiring ultrasound guidance and placement (e.g., endoscopy equipment or needle biopsy equipment). It is composed of either a single transducer element or an array of transducer elements [i.e., piezoelectric element(s), active element(s), or crystal(s) and associated damping, backing, and matching layer materials]. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
OBJ Catheter, Ultrasound, Intravascular
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K050995 000
K080891 000
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Sterilization

Yes
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

81b97793-1b96-4f43-a652-60d8b1026898
July 06, 2018
3
August 23, 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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No
Yes
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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