Identity
- Trade Name
- NDI Passive Spheres FDA UDI
- Generic Name
- Imaging lesion localization marker, external, single-use FDA UDI
- Device Name
- 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 10 sphere per tray in a pouch. There are 2 tray-in-pouches for a total of 20 spheres. FDA UDI
- Model / Reference
- 8801320 FDA 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 10 sphere per tray in a pouch. There are 2 tray-in-pouches for a total of 20 spheres. FDA UDI
Identifiers
- Catalog Number
- 8801320 FDA UDI
- Primary DI / UDI-DI
- 00805832030047 FDA UDI
- 510(k) Number
- K033621 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Imaging lesion localization marker, external, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Imaging lesion localization marker, external, single-use
NDI Passive Spheres by Northern Digital Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Imaging lesion localization marker, external, single-use.
- MEDWIRE — Medax Unipersonale Srl · Class I
- Xact — Solstice Corp. · Class I
- REAL INTELLIGENCE — Smith & Nephew, Inc. · Class II
- SINUREP — Medax Unipersonale Srl · Class I
- MEDWIRE — Medax Unipersonale Srl · Class I
- DKBL-20-7.0-A-U — IZI MEDICAL PRODUCTS LLC · Class I
- DXRBL-18-5.0 — IZI MEDICAL PRODUCTS LLC · Class I
- 7D Surgical FLASH Frame — 7D Surgical ULC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Northern Digital Inc
Sources (1)
- FDA UDI 4bb2e1af-d11b-4993-a0d2-7bd4855511c6 36 fields · synced May 31, 2026