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Guide rod

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 400196

by SI-BONE, Inc.

Identity

Trade Name
Navigation - Impactor, Removal Adapter, Rod & Thumbwheel FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Device Name
Guide rod EUDAMED
Navigation, Impactor, Removal Adapter, Rod & Thumbwheel FDA UDI
Model / Reference
400196 EUDAMEDFDA UDI
Description
Navigation, Impactor, Removal Adapter, Rod & Thumbwheel FDA UDI

Identifiers

Primary DI / UDI-DI
00851085007848 EUDAMEDFDA UDI
Basic UDI-DI
081005552GuideRodXN EUDAMED
Direct Marketing DI
00851085007848 EUDAMED
FDA Product Code
OLO FDA UDI
EMDN Code
L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
882.4560 FDA UDI
Market of Registration
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

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
MRI Safety
MR Conditional FDA UDI

The Guide Rod is a medical device used in the treatment of osteoporosis, designed to help manage bone density and reduce the risk of fractures. By providing accurate and reliable guidance on its use, this device enables healthcare professionals to make informed decisions about patient care.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SI-BONE, Inc.
EUDAMED SRN
US-MF-000028624
Authorised Representative
ICON (LR) Limited IE-AR-000006507

Sources (2)

  • EUDAMED 43687617-6347-4eac-929d-a964bdcd93b7 61 fields · synced Jul 10, 2026
  • FDA UDI a32f69fc-90d3-4ebe-9c49-69b50af91220 34 fields · synced May 29, 2026