Identity
- Trade Name
- MARTEAU DE JUDET 1000 g EUDAMEDOURY-GUYE & FILS FDA UDI
- Generic Name
- Surgical mallet FDA UDI
- Device Name
- Reusable surgical handling instruments - NON INVASIVE EUDAMEDJUDET HAMMER - 1KG FDA UDI
- Model / Reference
- ZD1437M EUDAMEDA FDA UDI
- Description
- JUDET HAMMER - 1KG FDA UDI
Identifiers
- Catalog Number
- ZD1437M FDA UDI
- Primary DI / UDI-DI
- 03665624004390 EUDAMEDFDA UDI
- Basic UDI-DI
- 03665624INST03J8 EUDAMED
- Direct Marketing DI
- 03665624004390 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0903 ORTHOPAEDIC SURGERY HAMMERS, REUSABLE EUDAMED
- GMDN Term
- Surgical mallet FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- France 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
MARTEAU DE JUDET 1000 g by Etablissements Oury Guye Et Fils — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 03665624INST03J8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Etablissements OURY-GUYE et Fils
- EUDAMED SRN
- FR-MF-000020162
Sources (2)
- EUDAMED 2d721c73-4d1f-4d8b-b051-703ad491451a 61 fields · synced Jul 10, 2026
- FDA UDI c8506d7f-ed97-4903-8fe6-2ff4bd9455ab 35 fields · synced May 30, 2026