Identity
- Trade Name
- AESCULAP AICON EUDAMEDAICON FDA UDI
- Generic Name
- Surgical instrument/implant rack FDA UDI
- Device Name
- AICON Baskets EUDAMEDDIN AESCULAP AICON BASKET 35MM FDA UDI
- Model / Reference
- JJ461R EUDAMEDFDA UDI
- Description
- DIN AESCULAP AICON BASKET 35MM FDA UDI
Identifiers
- Catalog Number
- JJ461R FDA UDI
- Primary DI / UDI-DI
- 04046955328666 EUDAMEDFDA UDI
- Basic UDI-DI
- 403923900000053123 EUDAMED
- Direct Marketing DI
- 04046955328666 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Surgical instrument/implant rack FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
No
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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument/implant rack
Aicon by Aesculap, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument/implant rack.
- MOBIO™ Total Knee System — b-ONE Ortho Corp. · Class I
- VASSOIO GAMMAFIX DOI ROSA — MEDESY srl · Class I
- LOQTEQ® — aap Implantate AG · Class I
- 1208 — Siam intermagnate CO.,LTD. · Class I
- VASSOIO GAMMAFIX CINC AZZURRO — MEDESY srl · Class I
- Accessories, arthroscopic — PARCUS MEDICAL LLC · Class I
- SPIRECUT — Spirecut AG · Class I
- MATRIXWAVE — Synthes · Class I
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aesculap, Inc.
Sources (2)
- FDA UDI 127ad3df-1575-44e3-a48e-ec1b7ca35ad7 35 fields · synced Jul 9, 2026
- EUDAMED 4d4d7d90-ad00-440d-bf4f-9b1126065781 61 fields · synced Jul 9, 2026