← Back to catalogue
An01-90018
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AN01-90018Model Canyon Retractor Systems Port Illuminator – 26mm
Identity
- Trade Name
- K2M Cayon Retractor System Port Illuminator 26mm FDA UDI
- Generic Name
- Open surgical site internal light FDA UDI
- Model / Reference
- Canyon Retractor Systems Port Illuminator – 26mm EUDAMEDAN01-90018 EUDAMED012065 FDA UDI
Identifiers
- Catalog Number
- AN01-90018 FDA UDI
- Primary DI / UDI-DI
- 00812432021283 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00812432021283 EUDAMED
- FDA Product Code
- FDG FDA UDI
- EMDN Code
- V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
- GMDN Term
- Open surgical site internal light FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 876.4530 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical retractor/retraction system blade, single-use
An01-90018 by Lumitex Medical Devices, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retractor/retraction system blade, single-use.
- AUTOMOTIVE KIT DIN13164-2022 in 2 PE bag — Bestreat Safety & First Aid Solution Co., Ltd. · Class I
- NEW DIN13169:2021 PLUS in GKB304 orange ABS box with two colors print, size: 38.5x27.2x13.8cm — Gauke Healthcare Co., Ltd · Class I
- First aid kits — Gauke Healthcare Co., Ltd · Class I
- BE COMBIKIT BLACK (Gdh+Vest+verbandset) — Hubei V-Medical Products Co.,Ltd. · Class I
- VERBANDDOOS LEGAAL JODIMA-ref 10.0046 compleet — Hubei V-Medical Products Co.,Ltd. · Class I
- Combi-bag PLUS FILLING, Shrink Foil pack-C3-2050 — Bestreat Safety & First Aid Solution Co., Ltd. · Class I
- PHARMACAR RED BAG — Bestreat Safety & First Aid Solution Co., Ltd. · Class I
- Coil Pack - Essentials — Clonallon Laboratories Ltd · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00812432021283 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lumitex Medical Devices, Inc.
- EUDAMED SRN
- US-MF-000030520
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 69f20690-1e85-4b26-b803-420847b9b333 61 fields · synced Jun 19, 2026
- FDA UDI bb9fd4cb-00e3-453c-a518-f0a47e52c8c9 33 fields · synced May 30, 2026