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Disposable Reflective Marker Spheres (DRMS)
FDA UDIEUDAMEDClass II (US FDA UDI)
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 2 spheres per tray, 30 trays, 60 spheres total. FDA UDI
- Model / Reference
- 41813 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 2 spheres per tray, 30 trays, 60 spheres total. FDA UDI
Identifiers
- Catalog Number
- 41813 FDA UDI
- Primary DI / UDI-DI
- 20805832010036 FDA UDI
- FDA Product Code
- OLO FDA UDIHAW 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 — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Northern Digital Inc
Sources (2)
- FDA UDI f518b3ac-166b-49d6-b2ed-368c1814601a 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026