DEVICE: SMITHWICK Carotid Shunt (00858764006161)
Device Identifier (DI) Information
SMITHWICK Carotid Shunt
SDS1209
In Commercial Distribution
SDS1209
Implantable Devices
SDS1209
In Commercial Distribution
SDS1209
Implantable Devices
Doppler Carotid Shunt 12 Fr. To 9 Fr., 15 cm long
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
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47113 | Carotid artery shunt |
A sterile device designed to serve as a temporary blood conduit (a shunt) connecting the distal internal carotid artery to the proximal common carotid artery allowing intravascular blood to continuously flow to the patient's brain during an endarterectomy procedure. It is typically designed as a hollow shaft with atraumatic dilations (e.g., balloons) on either end. The shaft is inserted into the lumen of the blood vessel, via a small incision at the surgical site. It is typically made of silicone elastomer and polyester radiopaque materials and is available in a range of diameters. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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DXC | Clamp, Vascular |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K021608 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
1347488a-ffb0-4b62-87de-dc45134a09b2
July 06, 2018
3
October 24, 2016
July 06, 2018
3
October 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
727-526-9159
implantabledevices@gmail.com
implantabledevices@gmail.com