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Ultrasound Transducer Cover

FDA UDI

Class II (US FDA UDI)

by Vitrolife Sweden AB

Identity

Trade Name
Ultrasound Transducer Cover FDA UDI
Generic Name
Body-orifice ultrasound imaging transducer cover, basic FDA UDI
Model / Reference
14221 FDA UDI

Identifiers

Primary DI / UDI-DI
07350025911618 FDA UDI
510(k) Number
K241662 FDA UDI
FDA Product Code
ITX FDA UDI
GMDN Term
Body-orifice ultrasound imaging transducer cover, basic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1570 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

Yes

FDA UDI

Category: Body-orifice ultrasound imaging transducer cover, basic

Ultrasound Transducer Cover by Vitrolife Sweden AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Body-orifice ultrasound imaging transducer cover, basic.

Cleared under the same submission

K241662 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
Vitrolife Sweden AB

Sources (1)

  • FDA UDI 05868508-1537-4535-bf67-814909f0aac1 33 fields · synced Jun 1, 2026