Humeral IM reamer Ø8.5 x 345 mm, can. Ø2.3 mm Hudson coup.

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref T14039Model IM Reamer Monobloc

by MPS Micro Precision Systems AG

Identity

Trade Name: Humeral IM reamer Ø8.5 x 345 mm, can. Ø2.3 mm Hudson coup. EUDAMEDFDA UDI
Generic Name: Medullary canal orthopaedic reamer, flexible FDA UDI
Model / Reference: T14039 EUDAMEDFDA UDI
IM Reamer Monobloc EUDAMED

Identifiers

Catalog Number: T14039 FDA UDI
Primary DI / UDI-DI: 07640187917819 EUDAMEDFDA UDI
Basic UDI-DI: 764018791IMREAMMONO01DH EUDAMED
Direct Marketing DI: 07640187917819 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Medullary canal orthopaedic reamer, flexible

Humeral IM reamer Ø8.5 x 345 mm, can. Ø2.3 mm Hudson coup. by MPS Micro Precision Systems AG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class I	Unknown
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 (2)

FDA UDI 256e67e8-c5a2-474f-a153-a4a9cddb1841 34 fields · synced Jun 19, 2026
EUDAMED e512a958-0915-4ca0-9050-359ad3cd0e90 61 fields · synced Jun 19, 2026