DEVICE: CorPath Interventional Cockpit (00081628002101)

Device Identifier (DI) Information

CorPath Interventional Cockpit
101
In Commercial Distribution
101
CORINDUS, INC.
00081628002101
GS1

1
781746586 *Terms of Use
No description.
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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
Radiation shielding material, ionizing A radiation protection device that attenuates ionizing radiation used to create barriers between an individual or a specific body part and a source of primary or scattered radiation used in medical or dental procedures. This GMDN code includes a variety of materials, e.g., lead (Pb) bricks and sheets, lead-equivalent materials, leaded glass or plastic, tungsten (W), low molecular weight plastics or hydrogenous materials. Examples of use can be: lead bricks to build protective structures, lead sheets used in walls and doors, leaded glass or leaded-plastic sheets used in windows, mouldable lead-equivalent plastic or thermoplastic materials used to shield specific anatomical areas.
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FDA Product Code

[?]
Product Code Product Code Name
IWX Barrier, Control Panel, X-Ray, Movable
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

dcf49c0c-7467-4df6-a986-5192bea130a7
March 29, 2018
2
November 16, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

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

[?]
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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
508-653-3335
customer.service@corindus.com
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