← Back to catalogue
8800967 NDI Sterile Passive Spheres +2 more models
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 8800967
Identity
- Trade Name
- NDI Passive Spheres FDA UDI
- Generic Name
- Imaging lesion localization marker, external, single-use FDA UDI
- Device Name
- 8800967 NDI Sterile Passive Spheres; 12 spheres per tray; 2 trays per box. Total 24 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 12 spheres per tray in a pouch. There are 2 tray-in-pouches for a total of 24 spheres. FDA UDI
- Model / Reference
- 8800967 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 12 spheres per tray in a pouch. There are 2 tray-in-pouches for a total of 24 spheres. FDA UDI
Identifiers
- Catalog Number
- 8800967 FDA UDI
- Primary DI / UDI-DI
- D-88009673L EUDAMED00805832030023 FDA UDI
- Basic UDI-DI
- B-88009673L 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
8800967 NDI Sterile Passive Spheres +2 more models by Northern Digital Inc — Class I — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — 3 models
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K033621 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-88009673L | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Northern Digital Inc.
- EUDAMED SRN
- CA-MF-000023503
- Authorised Representative
- NDI Europe GmbH DE-AR-000019156
Sources (3)
- EUDAMED 88c5035e-c915-44a5-b2fa-9d01308c7719 61 fields · synced Jun 19, 2026
- FDA UDI 7e797110-75ad-4960-97d1-e88b88ac16ba 36 fields · synced May 29, 2026
- FDA 510(k) K033621 1 fields · synced May 18, 2026