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Smr System

FDA UDI

Class II (US FDA UDI)

by Limacorporate

Identity

Trade Name
SMR SYSTEM FDA UDI
Generic Name
Orthopaedic reamer guide FDA UDI
Device Name
CMI Reamer Guide FDA UDI
Model / Reference
9CC0.95.097 FDA UDI
Description
CMI Reamer Guide FDA UDI

Identifiers

Catalog Number
9CC0.95.097 FDA UDI
Primary DI / UDI-DI
08033390164368 FDA UDI
510(k) Number
K110598 FDA UDI
FDA Product Code
KWS FDA UDI
GMDN Term
Orthopaedic reamer guide FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3660 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

Smr System by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K110598 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Limacorporate

Sources (1)

  • FDA UDI d36f2e74-dea9-4ff4-aee0-0e5dcabc8bff 36 fields · synced Jun 1, 2026