DEVICE: Scanlan® RADIOMARK® graft markers (00846159025644)

Device Identifier (DI) Information

Scanlan® RADIOMARK® graft markers
1001-831B
In Commercial Distribution
1001-831B
SCANLAN INTERNATIONAL INC
00846159025644
GS1

10
023055619 *Terms of Use
Disk-shaped style, silicone, bulk NS, 10 per pk
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Device Characteristics

MR Safe
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
60867 Polymeric coronary bypass marker
A device intended to be implanted during coronary artery bypass graft surgery, at the point of the arterial anastomosis, to provide clear postsurgical radiographic verification of the arterial anastomosis. It is in the form of a synthetic polymer ring (e.g., silicone) impregnated with a metal [e.g., tungsten (W)] to aid visualization, and is compatible with the imaging system with which it is intended to be visualized/exposed [e.g., magnetic resonance imaging (MRI), fluoroscopy].
Active true
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FDA Product Code

[?]
Product Code Product Code Name
MAB Marker, Cardiopulmonary Bypass (Vein Marker)
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FDA Premarket Submission

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

Sterilization

No
Yes
Sterilization Method [?]
Ethylene Oxide
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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

227e9fed-d500-4f8f-9691-1fbb239500e5
February 05, 2021
3
August 27, 2015
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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: 00846159029444 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
651 298-0997
vanderpoelw@scanlangroup.com
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