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M/Dn®

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name
M/DN® FDA UDI
Generic Name
Humerus intramedullary nail FDA UDI
Model / Reference
2254-285-08 FDA UDI

Identifiers

Catalog Number
00-2254-285-08 FDA UDI
Primary DI / UDI-DI
00889024045743 FDA UDI
510(k) Number
K965098 FDA UDI
FDA Product Code
HSB FDA UDI
GMDN Term
Humerus intramedullary nail FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3020 FDA UDI
Commercial Distribution
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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 28.5 Centimeter FDA UDI

Category: Humerus intramedullary nail

M/Dn® by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Humerus intramedullary nail.

Cleared under the same submission

K965098 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zimmer, Inc.

Sources (1)

  • FDA UDI e08ff6e4-0116-47e6-8061-c3400799b446 36 fields · synced Jun 6, 2026