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McKesson

FDA UDI

Class II (US FDA UDI)

by Mckesson Medical-Surgical Inc.

Identity

Trade Name
McKesson FDA UDI
Generic Name
Body-surface ultrasound imaging transducer cover FDA UDI
Device Name
Probe Cover FDA UDI
Model / Reference
16-1005 FDA UDI
Description
Probe Cover FDA UDI

Identifiers

Primary DI / UDI-DI
20612479202850 FDA UDI
510(k) Number
K022156 FDA UDI
FDA Product Code
ITX FDA UDI
GMDN Term
Body-surface ultrasound imaging transducer cover 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

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: Body-surface ultrasound imaging transducer cover

McKesson by Mckesson Medical-Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Body-surface ultrasound imaging transducer cover.

Cleared under the same submission

K022156 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mckesson Medical-Surgical Inc.

Sources (1)

  • FDA UDI c5afd49f-92fa-4825-ac37-91e7c3cc7866 34 fields · synced May 30, 2026