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Devon

FDA UDI

Class II (US FDA UDI)

by Cardinalhealth

Identity

Trade Name
Devon FDA UDI
Generic Name
Medical equipment handle cover, single-use, non-sterile FDA UDI
Device Name
3600-10B EURO DAI-ICHI HOSPILITE X1 FDA UDI
Model / Reference
50000995 FDA UDI
Description
3600-10B EURO DAI-ICHI HOSPILITE X1 FDA UDI

Identifiers

Catalog Number
50000995 FDA UDI
Primary DI / UDI-DI
10884521643574 FDA UDI
FDA Product Code
FSY FDA UDI
GMDN Term
Medical equipment handle cover, single-use, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4580 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

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Medical equipment handle cover, single-use, non-sterile

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

Similar devices

Also classified as Medical equipment handle cover, single-use, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinalhealth

Sources (1)

  • FDA UDI 08a5d713-84a4-4348-be4c-746aeaaadb61 36 fields · synced May 30, 2026