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Vascular Probe

FDA UDI

Class II (US FDA UDI)

by Synovis Life Technologies, Inc.

Identity

Trade Name
Vascular Probe FDA UDI
Generic Name
Intravascular probe, single-use FDA UDI
Device Name
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. FDA UDI
Model / Reference
7452025 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
7452025 FDA UDI
Primary DI / UDI-DI
00085412532608 FDA UDI
510(k) Number
K130896 FDA UDI
FDA Product Code
DWP FDA UDI
GMDN Term
Intravascular probe, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4475 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Intravascular probe, single-use

Vascular Probe by Synovis Life Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravascular probe, single-use.

Cleared under the same submission

K130896 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synovis Life Technologies, Inc.

Sources (1)

  • FDA UDI 4d0b671d-2038-42ae-a91e-0f302058cffd 36 fields · synced May 30, 2026