AccessGUDID - DEVICE: Vascular Probe (00085412532608)

GUDID

Device Identifier (DI) Information

Brand Name: Vascular Probe
Version or Model: 7452025
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7452025
Company Name: SYNOVIS LIFE TECHNOLOGIES, INC.

Primary DI Number: 00085412532608
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017415781 *Terms of Use

Device Description: 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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.

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4d0b671d-2038-42ae-a91e-0f302058cffd
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016