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Hudson motor shaft - Offset Reamer Handle

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref S03273Ref 131-174/04B

by Incipio Devices SA

Identity

Trade Name
Hudson motor shaft - Offset Reamer Handle EUDAMED
Offset reamer handle - Hudson motor shaft FDA UDI
Generic Name
Surgical power tool adaptor FDA UDI
Device Name
Offset Reamer Handle EUDAMED
Offset Reamer Handle power coupling accessory FDA UDI
Model / Reference
S03273 EUDAMED
131-174/04B EUDAMED
50244508 FDA UDI
Description
Offset Reamer Handle power coupling accessory FDA UDI

Identifiers

Catalog Number
10-502-457-08 FDA UDI
Primary DI / UDI-DI
07630055305732 EUDAMEDFDA UDI
07630055306852 EUDAMED
Basic UDI-DI
7630055300502445ORHBT EUDAMED
Direct Marketing DI
07630055305732 EUDAMED
07630055306852 EUDAMED
FDA Product Code
LXH FDA UDI
EMDN Code
L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
GMDN Term
Surgical power tool adaptor FDA UDI

Classification

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

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Hudson motor shaft - Offset Reamer Handle by Incipio Devices SA — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Incipio Devices SA
EUDAMED SRN
CH-MF-000030518
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (3)

  • EUDAMED 9d9d4dac-74d8-49a7-9d09-c9ccdc63b931 61 fields · synced Jul 19, 2026
  • EUDAMED 93999106-9948-432c-971f-35edabce3f6e 61 fields · synced May 17, 2026
  • FDA UDI 4cda8a4f-ad9f-4c13-92f1-d59b330d4b55 34 fields · synced May 30, 2026