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Water Standoff Collar

FDA UDI

Class II (US FDA UDI)

by Bk Medical ApS

Identity

Trade Name
Water Standoff Collar FDA UDI
Generic Name
Ultrasound imaging transducer cover connector FDA UDI
Device Name
Water Standoff Collar for 20R3 / 9052 Transducer FDA UDI
Model / Reference
UA0671 FDA UDI
Description
Water Standoff Collar for 20R3 / 9052 Transducer FDA UDI

Identifiers

Primary DI / UDI-DI
05704916001346 FDA UDI
510(k) Number
K173569 FDA UDI
K180737 FDA UDI
K223830 FDA UDI
FDA Product Code
ITX FDA UDI
GMDN Term
Ultrasound imaging transducer cover connector 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ultrasound imaging transducer cover connector

Water Standoff Collar by Bk Medical ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K173569 also covers:

K180737 also covers:

K223830 also covers:

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 ba2903c2-5abf-48fb-8084-1cff97030f51 35 fields · synced Jun 7, 2026