Identity
- Trade Name
- Ez Trax FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Insert Stainless Steel (L)21 (W)12 (H)2 FDA UDI
- Model / Reference
- INSERT.SS.21.12.2 FDA UDI
- Description
- Insert Stainless Steel (L)21 (W)12 (H)2 FDA UDI
Identifiers
- Catalog Number
- INSERT.SS.21.12.2 FDA UDI
- Primary DI / UDI-DI
- 00850006159086 FDA UDI
- FDA Product Code
- KCT FDA UDI
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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
No
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 II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- K1 Medical Technologies, Llc
Sources (1)
- FDA UDI 4cbbc095-d619-4f3b-a3a4-5fc8c01869ed 35 fields · synced Jun 8, 2026