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Devon

FDA UDI

Class II (US FDA UDI)

by Cardinalhealth

Identity

Trade Name
Devon FDA UDI
Generic Name
Circumcision kit, single-use FDA UDI
Device Name
True content to be populated as part of rebranding FDA UDI
Model / Reference
52000034 FDA UDI
Description
True content to be populated as part of rebranding FDA UDI

Identifiers

Catalog Number
52000034 FDA UDI
Primary DI / UDI-DI
20884527023100 FDA UDI
510(k) Number
K040052 FDA UDI
FDA Product Code
HFX FDA UDI
GMDN Term
Circumcision kit, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.4530 FDA UDI
Commercial Distribution
Not 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

Yes

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

Devon by Cardinalhealth — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K040052 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinalhealth

Sources (1)

  • FDA UDI 208a1b89-3ebd-4423-84f7-8d7f304a15a3 37 fields · synced Jun 6, 2026