AccessGUDID - DEVICE: Vascular Probe (00085412532530)

GUDID

Device Identifier (DI) Information

Brand Name: Vascular Probe
Version or Model: 7081520
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7081520
Company Name: SYNOVIS LIFE TECHNOLOGIES, INC.

Primary DI Number: 00085412532530
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47846	Intravascular probe, single-use	A slender, rod-like, hand-held manual surgical instrument intended to facilitate vessel stenting, retraction, and occlusion. It 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 may be single- or double-ended with a blunt bulbous tip (an olive) at the working end(s); It is typically made of polyester/silicone materials and is available in various sizes. This is a single-use device.	Active	false

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: 3f9a6e92-ad9e-4915-813c-0834e738b2a3
Public Version Date: January 20, 2023
Public Version Number: 5
DI Record Publish Date: September 24, 2016