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Spreader 13mm Height
EUDAMEDClass I (EU MDR)
Ref 03.809.877Model Reusable instrumentation
Identity
- Trade Name
- SPREADER 13MM HEIGHT EUDAMED
- Model / Reference
- Reusable instrumentation EUDAMED03.809.877 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00843193117571 EUDAMED
- Basic UDI-DI
- 08431931InstrumentsU5 EUDAMED
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Orthopaedic implant impactor, reusable
Discover the SPREADER 13MM HEIGHT, a versatile and reliable medical device designed for spinal surgery. With its reusable design and standard FDA clearance, this instrument is ideal for various applications. Learn more about its key features, compliance, and FAQs.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08431931InstrumentsU5 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Centinel Spine, LLC
- EUDAMED SRN
- US-MF-000013245
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED a7a84488-8bc5-470d-bc10-a7bccfb3f0be 61 fields · synced Aug 3, 2026