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Nexel®

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name
Nexel® FDA UDI
Generic Name
Elbow humerus prosthesis trial FDA UDI
Model / Reference
00-8401-046-10 FDA UDI

Identifiers

Catalog Number
00-8401-046-10 FDA UDI
Primary DI / UDI-DI
00889024271869 FDA UDI
510(k) Number
K123862 FDA UDI
FDA Product Code
JDC FDA UDI
GMDN Term
Elbow humerus prosthesis trial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3150 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

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 100 Millimeter FDA UDI

Category: Elbow humerus prosthesis trial

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

Similar devices

Also classified as Elbow humerus prosthesis trial.

Cleared under the same submission

K123862 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 7ad33bd9-14e5-4db3-9e3a-4e62f7c062e5 36 fields · synced May 30, 2026