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Millen

FDA UDI

Class II (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name
Millen FDA UDI
Generic Name
Ossicular prosthesis, total FDA UDI
Device Name
PROSTHESIS 0564 MILLEN FLEX H/A OFF TOT FDA UDI
Model / Reference
0564 FDA UDI
Description
PROSTHESIS 0564 MILLEN FLEX H/A OFF TOT FDA UDI

Identifiers

Primary DI / UDI-DI
00681490024785 FDA UDI
510(k) Number
K885201 FDA UDI
FDA Product Code
ETA FDA UDI
GMDN Term
Ossicular prosthesis, total FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3495 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 9.0 Millimeter FDA UDI

Millen by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K885201 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Xomed, Inc.

Sources (1)

  • FDA UDI 5f69bda3-1038-4f3b-9a69-3c26aedafdc3 37 fields · synced May 30, 2026