Identity
- Trade Name
- Ez Trax FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Base Assembly Stainless Steel (L)24 (W)12 (H)4 FDA UDI
- Model / Reference
- BASEASSY.SS.24.12.4 FDA UDI
- Description
- Base Assembly Stainless Steel (L)24 (W)12 (H)4 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850006159154 FDA UDI
- FDA Product Code
- FSM FDA UDI
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Ez Trax by K1 Medical Technologies, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- K1 Medical Technologies, Llc
Sources (1)
- FDA UDI 517693cf-da93-42d7-adff-bcc2e5bcae09 34 fields · synced Jun 8, 2026