Identity
- Trade Name
- E9000 EUDAMEDNA FDA UDI
- Generic Name
- Surgical instrument guard, reusable FDA UDI
- Device Name
- Orthopedic, Non-active, Bur Guard, E9000 EUDAMEDE9000 MEDIUM NEURO GUARD FDA UDI
- Model / Reference
- E9011-8 EUDAMEDFDA UDI
- Description
- E9000 MEDIUM NEURO GUARD FDA UDI
Identifiers
- Catalog Number
- E9011-8 FDA UDI
- Primary DI / UDI-DI
- 30845854035539 EUDAMEDFDA UDI
- Basic UDI-DI
- B-30845854035539 EUDAMED
- FDA Product Code
- HRX FDA UDI
- EMDN Code
- L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical instrument guard, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Market of Registration
- Belgium 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
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone cutting forceps, reusable
E9000 by Conmed Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-30845854035539 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 6b90dd1c-b890-4a95-8615-72761eb3a656 61 fields · synced May 30, 2026
- FDA UDI 6000b3f6-7025-4841-bbbe-7caa61ef3be2 35 fields · synced May 30, 2026