← Back to catalogue
Midline Marker 8mm Width 250mm
EUDAMEDFDA UDIClass I (EU MDR)
Ref 03.605.009Model Reusable instrumentation
Identity
- Trade Name
- MIDLINE MARKER 8MM WIDTH 250MM EUDAMEDSTALIF C FDA UDI
- Generic Name
- Polymeric spinal fusion cage, sterile FDA UDI
- Model / Reference
- Reusable instrumentation EUDAMED03.605.009 EUDAMEDC145541-3T FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815101020006 EUDAMEDFDA UDI
- Basic UDI-DI
- 08431931InstrumentsU5 EUDAMED
- 510(k) Number
- K120819 FDA UDI
- FDA Product Code
- OVE FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Polymeric spinal fusion cage, sterile FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Midline Marker 8mm Width 250mm by Centinel Spine, LLC — 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 | 08431931InstrumentsU5 | Class I | Active |
| 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
- Centinel Spine, LLC
- EUDAMED SRN
- US-MF-000013245
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 320fdc8a-b442-4bd7-94fd-15e058f142e3 61 fields · synced Jun 18, 2026
- FDA UDI 19fff6c8-6dfc-4069-b1d6-fb0fbcc19ad4 33 fields · synced May 29, 2026