← Back to catalogue

PrimeWire Prestige Plus Pressure Guide Wire 300cm ST

FDA UDI

Class II (US FDA UDI)

by Volcarica S.R.L.

Identity

Trade Name
PrimeWire Prestige Plus Pressure Guide Wire 300cm ST FDA UDI
Generic Name
Catheter-tip transducer, pressure FDA UDI
Model / Reference
9300 FDA UDI

Identifiers

Primary DI / UDI-DI
00845225001124 FDA UDI
510(k) Number
K111395 FDA UDI
FDA Product Code
DQX FDA UDI
GMDN Term
Catheter-tip transducer, pressure FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1330 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Catheter-tip transducer, pressure

PrimeWire Prestige Plus Pressure Guide Wire 300cm ST by Volcarica S.R.L. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Catheter-tip transducer, pressure.

Cleared under the same submission

K111395 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Volcarica S.R.L.

Sources (1)

  • FDA UDI 7cd2fd25-553d-4b0a-8c02-1e5471fcec60 33 fields · synced Jun 8, 2026