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Emperion

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
EMPERION FDA UDI
Generic Name
Medullary canal orthopaedic reamer, rigid FDA UDI
Device Name
9.5MM MODULAR DISTAL REAMER FDA UDI
Model / Reference
71360967 FDA UDI
Description
9.5MM MODULAR DISTAL REAMER FDA UDI

Identifiers

Catalog Number
71360967 FDA UDI
Primary DI / UDI-DI
03596010535498 FDA UDI
510(k) Number
K123598 FDA UDI
FDA Product Code
JDG FDA UDI
GMDN Term
Medullary canal orthopaedic reamer, rigid FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3360 FDA UDI
Commercial Distribution
Not 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

Emperion by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K123598 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI 138e2f02-e014-4e37-951b-78b6db31c87e 37 fields · synced Jun 8, 2026