DEVICE: Vascular Probe Extra Supple (00085412532653)

Device Identifier (DI) Information

Vascular Probe Extra Supple
7151520ES
In Commercial Distribution
7151520ES
SYNOVIS LIFE TECHNOLOGIES, INC.
00085412532653
GS1

1
017415781 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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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.
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FDA Product Code

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Product Code Product Code Name
DWP DILATOR, VESSEL, SURGICAL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K130896 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

75b224d2-5aa5-41db-b59e-1d8e27e9329a
July 06, 2018
3
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
50085412532658 5 00085412532653 In Commercial Distribution CASE
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Secondary DI

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

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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

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)933-0303
Medinfo_medproducts@baxter.com
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