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AxoTrack I Sterile Procedure Kit
EUDAMEDFDA UDIClass I (EU MDR)
Ref P20810-03Model AXOTRACK I STERILE PROCEDURE KIT (18G XTW)
Identity
- Trade Name
- AxoTrack I Sterile Procedure Kit EUDAMEDFDA UDI
- Generic Name
- Ultrasound/electromagnetic-guided needle kit FDA UDI
- Device Name
- AXOTRACK I STERILE PROCEDURE KIT (18G XTW) EUDAMEDDiagnostic Ultrasound System Accessory. Sterile needle guidance kit to be used with P11x ultrasound transducer. FDA UDI
- Model / Reference
- AXOTRACK I STERILE PROCEDURE KIT (18G XTW) EUDAMEDP20810-03 EUDAMEDFDA UDI
- Description
- Diagnostic Ultrasound System Accessory. Sterile needle guidance kit to be used with P11x ultrasound transducer. FDA UDI
Identifiers
- Catalog Number
- P20810 FDA UDI
- Primary DI / UDI-DI
- 30841517100156 EUDAMEDFDA UDI
- Basic UDI-DI
- B-30841517100156 EUDAMED
- 510(k) Number
- K113680 FDA UDI
- FDA Product Code
- IYO FDA UDIITX FDA UDI
- EMDN Code
- Z1104018099 ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER EUDAMED
- GMDN Term
- Ultrasound/electromagnetic-guided needle kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
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
Dimensions & Sizes
- Size
- Needle Gauge — 18 Gauge FDA UDI
AxoTrack I Sterile Procedure Kit by Fujifilm Sonosite, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-30841517100156 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
- EUDAMED SRN
- US-MF-000001075
- Authorised Representative
- Fujifilm Sonosite B.V. NL-AR-000000046
Sources (2)
- EUDAMED d6435760-5e1a-430e-9f83-d46a43c63e17 61 fields · synced Jul 10, 2026
- FDA UDI ce6c7cb7-e4ed-4a0b-9976-f9fd3e140d51 38 fields · synced May 30, 2026