IM reamer head dove tail Ø9.5 x 22 mm, can. Ø3.1 mm

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref T18366Model IM Reamer HeadRef T16169Ref T14435

by MPS Micro Precision Systems AG

Identity

Trade Name: IM reamer head dove tail Ø9.5 x 22 mm, can. Ø3.1 mm EUDAMEDFDA UDI
IM reamer head dove tail Ø9.5 x 22 mm, can. Ø3.4 mm EUDAMED
Generic Name: Medullary canal orthopaedic reamer, flexible FDA UDI
Device Name: Intramedullary reamer head is used in combination with the Intramedullary reamer shaft 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. A range of diameter is proposed in regards with the nail to be implanted. Different coupling are available to connect the shaft with existing power tool. The device is reusable. FDA UDI
Model / Reference: IM Reamer Head EUDAMED
T18366 EUDAMEDFDA UDI
T16169 EUDAMED
T14435 EUDAMED
Description: Intramedullary reamer head is used in combination with the Intramedullary reamer shaft 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. A range of diameter is proposed in regards with the nail to be implanted. Different coupling are available to connect the shaft with existing power tool. The device is reusable. FDA UDI

Identifiers

Catalog Number: T18366 FDA UDI
Primary DI / UDI-DI: 07640187911718 EUDAMEDFDA UDI
07640187917314 EUDAMED
07640187916324 EUDAMED
Basic UDI-DI: 764018791IMREAMHEAD013G EUDAMED
FDA Product Code: HTO FDA UDI
EMDN Code: L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
GMDN Term: Medullary canal orthopaedic reamer, flexible FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Market of Registration: Austria EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

IM reamer head dove tail Ø9.5 x 22 mm, can. Ø3.1 mm by MPS Micro Precision Systems AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	764018791IMREAMHEAD013G	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: MPS Micro Precision Systems AG
EUDAMED SRN: CH-MF-000032439
Authorised Representative: Emergo Europe B.V. NL-AR-000000116

Sources (4)

EUDAMED 3247024a-b0e6-410d-9820-cd48088e25b2 61 fields · synced Oct 6, 2026
EUDAMED e6254312-60d6-4826-8ee8-9537a2e4f3e1 61 fields · synced May 17, 2026
EUDAMED f363d114-e816-48cc-93e8-41ef384720a1 61 fields · synced May 18, 2026
FDA UDI 9c90cfc5-c6cd-45bb-b792-d7e3c630a31a 35 fields · synced May 29, 2026