Identity
- Trade Name
- AESCULAP EUDAMEDFDA UDI
- Generic Name
- Bone file/rasp, manual, reusable FDA UDI
- Device Name
- Bone file/rasp EUDAMEDFOMON Bone Rasp, 8 1/2" (215 mm), double ended, toothed (fine coarse), width: 6,50 mm, 7,50 mm FDA UDI
- Model / Reference
- OL406R EUDAMEDFDA UDI
- Description
- FOMON Bone Rasp, 8 1/2" (215 mm), double ended, toothed (fine coarse), width: 6,50 mm, 7,50 mm FDA UDI
Identifiers
- Catalog Number
- OL406R FDA UDI
- Primary DI / UDI-DI
- 04038653178476 EUDAMEDFDA UDI
- Basic UDI-DI
- 403923900000130825 EUDAMED
- Direct Marketing DI
- 04038653178476 EUDAMED
- FDA Product Code
- GAC FDA UDI
- EMDN Code
- L140204 NASAL SURGERY RASPS AND FILES, REUSABLE EUDAMED
- GMDN Term
- Bone file/rasp, manual, reusable 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
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
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: Bone file/rasp, manual, reusable
Aesculap by Aesculap, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bone file/rasp, manual, reusable.
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class I
- NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
- Life Instruments — Life Instrument Corporation · Class I
- TALOS®-C — MEDITECH SPINE, LLC · Class II
- DeGen Standard Instrumentation — Degen Medical · Class I
- TiWave C Cervical Cage System — Kalitec Direct LLC · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- 4WEB Medical — 4Web Medical, Inc. · 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 9fcbc0f1-fd7c-41c0-b80f-44e6925647f9 35 fields · synced Jul 10, 2026
- EUDAMED 5a0a75da-bafb-4578-9513-4f3ad9d9a16b 61 fields · synced Jul 10, 2026