DEVICE: CenterCross Catheter (B094CC01000)

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Device Identifier (DI) Information

CenterCross Catheter
CC-0100

ROXWOOD MEDICAL, INC.
B094CC01000
HIBCC
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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
Blunt-microdissection atherectomy catheter A manually-powered instrument intended to be used to create a pathway through an occluded blood vessel to facilitate the intraluminal placement of a conventional guidewire beyond a stenotic lesion [especially a chronic total occlusion (CTO) of a coronary artery], prior to further percutaneous intervention to remove the lesion. It typically consists of a long, thin, flexible segment, introduced into the vasculature, that is equipped to mechanically disrupt the lesion (e.g., by blunt microdissection) through manipulation of hand controls at the proximal end. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
DQY Catheter, Percutaneous
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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 Status

In Commercial Distribution
April 27, 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
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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