Identity
- Trade Name
- Intracs® FDA UDI
- Generic Name
- Electromagnetic surgical navigation device tracking system FDA UDI
- Device Name
- joimax® Intracs® EM Navigation Sensor Tray 150 FDA UDI
- Model / Reference
- JINTST15 FDA UDI
- Description
- joimax® Intracs® EM Navigation Sensor Tray 150 FDA UDI
Identifiers
- Catalog Number
- JINTST15 FDA UDI
- Primary DI / UDI-DI
- 04250337118022 FDA UDI
- 510(k) Number
- K192663 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Electromagnetic surgical navigation device tracking system 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Electromagnetic surgical navigation device tracking system
Intracs® by Joimax, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K192663 also covers:
- Intracs® — JOIMAX, INC.
- Intracs® — JOIMAX, INC.
- Joimax® Intracs® EM Control Unit — JOIMAX, INC.
- Joimax® Intracs® EM Field Generator — JOIMAX, INC.
- Joimax® Intracs® EM K-Wire Drill Guide W 18 mm x D 28 mm x H 60 mm — JOIMAX, INC.
- Joimax® Intracs® EM Mounting Arm f field Generator mounting arm + rail clamp — JOIMAX, INC.
- Joimax® Intracs® EM Mounting Arm f. Patient Mapper mounting arm + rail clamp — JOIMAX, INC.
- Joimax® Intracs® EM Panel PC — JOIMAX, INC.
- Joimax® Intracs® EM Patient Mapper - AP — JOIMAX, INC.
- Joimax® Intracs® EM Patient Mapper - LAT — JOIMAX, INC.
- Joimax® Intracs® EM Patient Tracker — JOIMAX, INC.
- Joimax® Intracs® EM Sensor Clip — JOIMAX, INC.
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
- Joimax, Inc.
Sources (1)
- FDA UDI 6cf068be-c7e6-46a8-af53-94dfb23efcaa 37 fields · synced Jun 1, 2026