DEVICE: SCANLAN® A/C Locator® graft marker (00846159001037)
Device Identifier (DI) Information
SCANLAN® A/C Locator® graft marker
1001-83
In Commercial Distribution
1001-83
SCANLAN INTERNATIONAL INC
1001-83
In Commercial Distribution
1001-83
SCANLAN INTERNATIONAL INC
U-shaped style, silicone (1 per sterile pkg)
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MAB | Marker, Cardiopulmonary Bypass (Vein Marker) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
11bc2254-09a3-42cc-990c-0f757fb74687
February 05, 2021
3
August 28, 2015
February 05, 2021
3
August 28, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10846159001034 | 10 | 00846159001037 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
6512980997
vanderpoelw@scanlangroup.com
vanderpoelw@scanlangroup.com