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Vapr Coolpulse

FDA UDI

Class II (US FDA UDI)

by DePuy Mitek, Inc.

Identity

Trade Name
VAPR COOLPULSE FDA UDI
Generic Name
Endoscopic electrosurgical electrode, bipolar, single-use FDA UDI
Device Name
VAPR COOLPULSE 90 Electrode 90 DEGREES Suction with Integrated Handpiece FDA UDI
Model / Reference
228146 FDA UDI
Description
VAPR COOLPULSE 90 Electrode 90 DEGREES Suction with Integrated Handpiece FDA UDI

Identifiers

Catalog Number
228146 FDA UDI
Primary DI / UDI-DI
10886705010080 FDA UDI
FDA Product Code
HRX FDA UDI
GEI FDA UDI
GMDN Term
Endoscopic electrosurgical electrode, bipolar, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.1100 FDA UDI
878.4400 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: Endoscopic electrosurgical electrode, bipolar, single-use

Vapr Coolpulse by DePuy Mitek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic electrosurgical electrode, bipolar, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DePuy Mitek, Inc.

Sources (1)

  • FDA UDI 102a8456-6415-4102-b808-7ecfc0acc370 35 fields · synced May 31, 2026