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8800966 NDI Sterile Passive Spheres +2 more models
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8800966
Identity
- Trade Name
- NDI Passive Spheres FDA UDI
- Generic Name
- Imaging lesion localization marker, external, single-use FDA UDI
- Device Name
- 8800966 NDI Sterile Passive Spheres; 15 spheres per tray; 2 trays per box. Total 30 spheres per box EUDAMEDDisposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 15 spheres per tray in a pouch. There are 2 tray-in-pouches for a total of 30 spheres. FDA UDI
- Model / Reference
- 8800966 EUDAMEDFDA UDI
- Description
- Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 15 spheres per tray in a pouch. There are 2 tray-in-pouches for a total of 30 spheres. FDA UDI
Identifiers
- Catalog Number
- 8800966 FDA UDI
- Primary DI / UDI-DI
- D-88009663J EUDAMED00805832030030 FDA UDI
- Basic UDI-DI
- B-88009663J EUDAMED
- 510(k) Number
- K033621 FDA UDI
- FDA Product Code
- HAW FDA UDI
- EMDN Code
- Z12130485 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Imaging lesion localization marker, external, single-use FDA UDI
- Models / Variants
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
8800966 NDI Sterile Passive Spheres +2 more models by Northern Digital Inc — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — 3 models
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-88009663J | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Northern Digital Inc.
- EUDAMED SRN
- CA-MF-000023503
- Authorised Representative
- NDI Europe GmbH DE-AR-000019156
Sources (2)
- EUDAMED 9a75f76c-ee87-4335-a161-377e240f003d 61 fields · synced Jul 30, 2026
- FDA UDI 69a1ee08-c7d0-4b31-853e-b845d79000c7 36 fields · synced May 30, 2026