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8800737 NDI Sterile Passive Spheres +2 more models
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8800737
Identity
- Trade Name
- NDI Passive Spheres FDA UDI
- Generic Name
- Imaging lesion localization marker, external, single-use FDA UDI
- Device Name
- 8800737 NDI Sterile Passive Spheres; 1 sphere per pouch; 5 pouches per box. Total 5 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 1 sphere per pouch with 1 pouch in another pouch. There are 5 pouch-in-pouches for a total of 5 spheres. FDA UDI
- Model / Reference
- 8800737 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 1 sphere per pouch with 1 pouch in another pouch. There are 5 pouch-in-pouches for a total of 5 spheres. FDA UDI
Identifiers
- Catalog Number
- 8800737 FDA UDI
- Primary DI / UDI-DI
- D-88007372Z EUDAMED00805832040015 FDA UDI
- Basic UDI-DI
- B-88007372Z 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
8800737 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-88007372Z | 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 cd41cf79-0822-4db8-a82c-7836e7a3ffb2 61 fields · synced Jun 18, 2026
- FDA UDI 240358f4-5d9e-4795-a392-99eaff2ee55c 36 fields · synced May 30, 2026