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Lubinus Classic Plus Hip Stem - Instruments
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 120-415/26Model Hip stem, cemented, CoCrMo, CCD 126°Ref 120-410/26Ref 120-405/26
Identity
- Trade Name
- Lubinus Classic Plus Hip Stem - Instruments FDA UDI
- Generic Name
- Surgical mallet FDA UDI
- Device Name
- Lubinus Classic Plus Hip Stem EUDAMEDSurgical mallet - General Instrument FDA UDI
- Model / Reference
- Hip stem, cemented, CoCrMo, CCD 126° EUDAMED120-415/26 EUDAMED120-410/26 EUDAMED120-405/26 EUDAMED130-165 FDA UDI
- Description
- Surgical mallet - General Instrument FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04026575219360 EUDAMED04026575219353 EUDAMED04026575219346 EUDAMED04026575031054 FDA UDI
- Basic UDI-DI
- 4026575-1-HSP-004001-VY EUDAMED
- FDA Product Code
- FZY FDA UDI
- EMDN Code
- P090804010101 CEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, STRAIGHT EUDAMED
- GMDN Term
- Surgical mallet FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical mallet
Lubinus Classic Plus Hip Stem - Instruments by WALDEMAR LINK GmbH & Co. KG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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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 |
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Manufacturer
- Manufacturer
- WALDEMAR LINK GmbH & Co. KG
Sources (4)
- FDA UDI 56b57f6f-53b8-496c-809e-4e69d7aeb1ed 33 fields · synced Jul 31, 2026
- EUDAMED 6e4bf709-faa1-4e6f-8985-21efce854bc2 61 fields · synced Jul 9, 2026
- EUDAMED f0b47917-17e5-44da-a0c1-b51078aec152 61 fields · synced Jul 20, 2026
- EUDAMED 95bf9868-e68d-4a08-a449-3b502898d0e7 61 fields · synced Jul 31, 2026