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8800738 NDI Sterile Passive Spheres +2 more models
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8800738
Identity
- Trade Name
- NDI Passive Spheres FDA UDI
- Generic Name
- Imaging lesion localization marker, external, single-use FDA UDI
- Device Name
- 8800738 NDI Sterile Passive Spheres; 3 spheres per pouch; 5 pouches per box. Total 15 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 3 pouches in another pouch. There are 5 pouch-in-pouches for a total of 15 spheres. FDA UDI
- Model / Reference
- 8800738 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 3 pouches in another pouch. There are 5 pouch-in-pouches for a total of 15 spheres. FDA UDI
Identifiers
- Catalog Number
- 8800738 FDA UDI
- Primary DI / UDI-DI
- D-880073833 EUDAMED00805832040022 FDA UDI
- Basic UDI-DI
- B-880073833 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
8800738 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-880073833 | 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 8b6ec0bb-6513-474f-9365-cdaa7b632645 61 fields · synced Jul 11, 2026
- FDA UDI 8f18a214-0019-4dda-97be-733c443faef9 36 fields · synced May 30, 2026