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8801054 NDI Sterile Passive Spheres +2 more models
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8801054
Identity
- Trade Name
- NDI Passive Spheres FDA UDI
- Generic Name
- Imaging lesion localization marker, external, single-use FDA UDI
- Device Name
- 8801054 NDI Sterile Passive Spheres; 4 spheres per tray; 12 trays per box. Total 48 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 4 sphere per tray in a pouch. There are 12 tray-in-pouches for a total of 48 spheres. FDA UDI
- Model / Reference
- 8801054 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 4 sphere per tray in a pouch. There are 12 tray-in-pouches for a total of 48 spheres. FDA UDI
Identifiers
- Catalog Number
- 8801054 FDA UDI
- Primary DI / UDI-DI
- D-880105425 EUDAMED00805832020031 FDA UDI
- Basic UDI-DI
- B-880105425 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
8801054 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-880105425 | 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 5d74c597-6c68-45a5-8df2-1983e00012fe 61 fields · synced Jun 18, 2026
- FDA UDI 538b1aee-8f68-4c07-90e8-a512e2ee7b6d 36 fields · synced May 30, 2026