DEVICE: Vascular Probe (00085412532608)
Device Identifier (DI) Information
Vascular Probe
7452025
In Commercial Distribution
7452025
SYNOVIS LIFE TECHNOLOGIES, INC.
7452025
In Commercial Distribution
7452025
SYNOVIS LIFE TECHNOLOGIES, INC.
The Vascular Probe is a sterile, single use, disposable polymeric device with a streamline bulb on each end of a flexible shaft. The bulbs are of different size on each end of the Vascular Probe.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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 |
---|---|
Intravascular probe | A sterile, rod-like, hand-held manual surgical instrument designed to facilitate vessel stenting, retraction, and occlusion. It is typically a flexible device with a blunt bulbous tip (an olive) at its distal end, or both ends, that is inserted into the vessel lumen via a small incision to locate occlusions, explore the proximal/distal artery for size, patency and location of stenosis, and to arrest blood flow (proximally, distally, or both) to enable operative field visualization during coronary or peripheral vascular bypass grafting and vessel repair surgery. It is typically made of polyester/silicone materials and is available in various sizes. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DWP | DILATOR, VESSEL, SURGICAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K130896 | 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
4d0b671d-2038-42ae-a91e-0f302058cffd
July 06, 2018
3
September 24, 2016
July 06, 2018
3
September 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 |
---|---|---|---|---|---|
50085412532603 | 5 | 00085412532608 | In Commercial Distribution | CASE |
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
[?]
+1(800)933-0303
Medinfo_medproducts@baxter.com
Medinfo_medproducts@baxter.com