Identity
- Trade Name
- IlluminOss Reusable Instruments EUDAMEDIlluminOss FDA UDI
- Generic Name
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
- Device Name
- Class 1r & 1m Reusable Surgical Instruments EUDAMEDFlex Stabilizer Tube 3.5” Long FDA UDI
- Model / Reference
- CT-0186 EUDAMEDFDA UDI
- Description
- Flex Stabilizer Tube 3.5” Long FDA UDI
Identifiers
- Catalog Number
- CT-0186 FDA UDI
- Primary DI / UDI-DI
- M986CT01860 EUDAMEDFDA UDI
- Basic UDI-DI
- ++M986FLEXTUBES9L EUDAMED
- Direct Marketing DI
- +M986CT01860D EUDAMED
- 510(k) Number
- DEN160062 FDA UDI
- FDA Product Code
- QAD FDA UDILXH FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3023 FDA UDI888.4540 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
Yes
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
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone pin, non-bioabsorbable
IlluminOss by Illuminoss Medical Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone pin, non-bioabsorbable.
- Steinmann Pins, K-Wire, smooth — Gebr. Brasseler GmbH & Co. KG · Class II
- KW03-310-18.A — newbox medical GmbH · Class IIb
- Steinmann Pins, K-Wire, smooth — Gebr. Brasseler GmbH & Co. KG · Class II
- XtraFix® External Fixation System — Zimmer, Inc. · Class II
- CALIBRATED GUIDE WIRE, THREADED TROCAR POINT — Biomet Orthopedics, Inc. · Class II
- TRAUMA FIXATION SYSTEMS — Biomet Orthopedics, Inc. · Class II
- SMART TSF — Smith & Nephew, Inc. · Class II
- KW02-300-20.A — newbox medical GmbH · Class IIb
Cleared under the same submission
DEN160062 also covers:
- IlluminOss — ILLUMINOSS MEDICAL INC.
- IlluminOss — ILLUMINOSS MEDICAL INC.
- IlluminOss — ILLUMINOSS MEDICAL INC.
- IlluminOss — ILLUMINOSS MEDICAL INC.
- IlluminOss — ILLUMINOSS MEDICAL INC.
- IlluminOss — ILLUMINOSS MEDICAL INC.
- IlluminOss — ILLUMINOSS MEDICAL INC.
- IlluminOss — ILLUMINOSS MEDICAL INC.
- IlluminOss — ILLUMINOSS MEDICAL INC.
- IlluminOss — ILLUMINOSS MEDICAL INC.
- IlluminOss — ILLUMINOSS MEDICAL INC.
- IlluminOss — ILLUMINOSS MEDICAL INC.
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Illuminoss Medical Inc.
Sources (2)
- FDA UDI a4ecbe3a-8a0d-4cfe-a331-6344dc5d8ea8 35 fields · synced Jul 11, 2026
- EUDAMED 3444760c-e900-41d5-adee-4d0233a82f5d 61 fields · synced Jul 11, 2026