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Navigator Standard Lymphactic Mapping Probe, 14mm, Wired, Angled
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref SP-2A14-67
Identity
- Trade Name
- Navigator Standard Lymphatic Mapping Probe, 14mm, Wired, Angled EUDAMEDNavigator Standard Lymphactic Mapping Probe, 14mm, Wired, Angled FDA UDI
- Generic Name
- Hand-held-detector nuclear medicine system FDA UDI
- Device Name
- Navigator Standard Lymphatic Mapping Probe, 14mm, Wired, Angled EUDAMED
- Model / Reference
- SP-2A14-67 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- SP-2A14-67 FDA UDI
- Primary DI / UDI-DI
- 08100498400510 EUDAMED00810049840051 FDA UDI
- Basic UDI-DI
- B-08100498400510 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hand-held-detector nuclear medicine system
Navigator Standard Lymphactic Mapping Probe, 14mm, Wired, Angled by Dilon Technologies, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
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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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dilon Technologies, Inc.
Sources (2)
- FDA UDI 7a57ccd8-e61e-4e1e-85c4-69787e5ca4e4 33 fields · synced Jul 11, 2026
- EUDAMED 3e135b5a-7a3a-4ae9-92ab-c3160bfdc5d9 61 fields · synced Jul 11, 2026