Identity
- Trade Name
- Disposable Reflective Marker Spheres (DRMS) FDA UDI
- Generic Name
- Imaging lesion localization marker, external, single-use FDA UDI
- Device Name
- Disposable Reflective Marker Spheres (DRMS) attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 3 spheres per tray, 90 trays, 270 spheres total. FDA UDI
- Model / Reference
- 41774 FDA UDI
- Description
- Disposable Reflective Marker Spheres (DRMS) attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 3 spheres per tray, 90 trays, 270 spheres total. FDA UDI
Identifiers
- Catalog Number
- 41774 FDA UDI
- Primary DI / UDI-DI
- 20805832010029 FDA UDI
- FDA Product Code
- HAW FDA UDIOLO 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
Disposable Reflective Marker Spheres (DRMS) by Northern Digital Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Northern Digital Inc
Sources (1)
- FDA UDI 2fbf2eaf-d638-48c7-8169-57af673e99e4 35 fields · synced May 30, 2026