IM reamer shaft dove tail 470 mm, Big AO coup.

FDA UDI

Class I (US FDA UDI)

by MPS Micro Precision Systems AG

Identity

Trade Name: IM reamer shaft dove tail 470 mm, Big AO coup. FDA UDI
Generic Name: Medullary canal orthopaedic reamer, flexible FDA UDI
Device Name: Intramedullary reamer shaft is used in combination with the Intramedullary reamer head to ream the medullary cavity of long bones in traumatologic or limb lengthening surgery of the femur, tibia and humerus bones where medullary cavities need to be prepared prior to placing a nail. The intramedullary reamers are intended for use with a guide wire to permit to secure the assembly and a surgical drilling machine. The device is reusable. FDA UDI
Model / Reference: T18821 FDA UDI
Description: Intramedullary reamer shaft is used in combination with the Intramedullary reamer head to ream the medullary cavity of long bones in traumatologic or limb lengthening surgery of the femur, tibia and humerus bones where medullary cavities need to be prepared prior to placing a nail. The intramedullary reamers are intended for use with a guide wire to permit to secure the assembly and a surgical drilling machine. The device is reusable. FDA UDI

Identifiers

Catalog Number: T18821 FDA UDI
Primary DI / UDI-DI: 07640187918151 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Medullary canal orthopaedic reamer, flexible FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

FDA UDI

Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Medullary canal orthopaedic reamer, flexible

IM reamer shaft dove tail 470 mm, Big AO coup. by MPS Micro Precision Systems AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: MPS Micro Precision Systems AG

Sources (1)

FDA UDI fde7383b-3506-4b6e-adb5-8ee035d1fafc 35 fields · synced May 30, 2026