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Standard Instrument Set

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 400099

by SI-BONE, Inc.

Identity

Trade Name
Standard Instrument Set EUDAMEDFDA UDI
Generic Name
Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI
Device Name
Surgical Instrument Sets EUDAMED
Standard Instrument Set FDA UDI
Model / Reference
400099 EUDAMEDFDA UDI
Description
Standard Instrument Set FDA UDI

Identifiers

Primary DI / UDI-DI
00855369008958 EUDAMEDFDA UDI
Basic UDI-DI
081005552iFuseInstSetML EUDAMED
FDA Product Code
OJH FDA UDI
EMDN Code
L80 SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES EUDAMED
GMDN Term
Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
878.4800 FDA UDI
Medical Purpose
Surgical instrument sets for placing or removing SI-BONE implants EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Standard Instrument Set by Si-Bone Inc. — Class I — 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
SI-BONE, Inc.
EUDAMED SRN
US-PR-000044785

Sources (2)

  • EUDAMED ba8cac34-71be-46bb-b404-2ed3d5406f5e 61 fields · synced Jul 17, 2026
  • FDA UDI 8ccb6ac3-0d5c-44ef-87e4-cd7b6d2db4ce 34 fields · synced May 30, 2026