Identity
- Trade Name
- TruNode Single-Use Gamma Probe EUDAMEDTruNode Surgical Gamma Probe FDA UDI
- Generic Name
- Hand-held-detector nuclear medicine system FDA UDI
- Device Name
- TruNode Gamma Probe System EUDAMEDA sterile, wireless, battery operated probe used to detect and quantify gamma rays from Tc-99m and I-125 isotopes, communicated to the User Feedback Unit. FDA UDI
- Model / Reference
- 120-807605 EUDAMEDFDA UDI
- Description
- A sterile, wireless, battery operated probe used to detect and quantify gamma rays from Tc-99m and I-125 isotopes, communicated to the User Feedback Unit. FDA UDI
Identifiers
- Catalog Number
- 120-807605 FDA UDI
- Primary DI / UDI-DI
- 15420045512856 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455TRUNODEBSHD6 EUDAMED
- Direct Marketing DI
- 15420045512856 EUDAMED
- FDA Product Code
- IZD FDA UDI
- EMDN Code
- Z11029001 BETA/GAMMA DETECTORS EUDAMED
- GMDN Term
- Hand-held-detector nuclear medicine system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 892.1320 FDA UDI
- Market of Registration
- Belgium 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hand-held-detector nuclear medicine system
TruNode Surgical Gamma Probe by Hologic, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (2)
- FDA UDI ccddfaec-dc9a-480f-96c5-878e7981de4a 36 fields · synced Jun 18, 2026
- EUDAMED 201ecbab-078d-4216-b2ad-aebb6b65f2a7 61 fields · synced Jun 18, 2026