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Intraoperative Biplane Transducer

FDA UDI

Class II (US FDA UDI)

by Bk Medical ApS

Identity

Trade Name
Intraoperative Biplane Transducer FDA UDI
Generic Name
Surgical ultrasound imaging transducer FDA UDI
Device Name
Intraoperative imaging FDA UDI
Model / Reference
8824 FDA UDI
Description
Intraoperative imaging FDA UDI

Identifiers

Primary DI / UDI-DI
05704916000585 FDA UDI
FDA Product Code
ITX FDA UDI
GMDN Term
Surgical ultrasound imaging transducer 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical ultrasound imaging transducer

Intraoperative Biplane Transducer by Bk Medical ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical ultrasound imaging transducer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bk Medical ApS

Sources (1)

  • FDA UDI c82747e0-196d-4312-94ad-337d4b987271 34 fields · synced Jun 1, 2026