Identity
- Trade Name
- Triangle Template Kit FDA UDI
- Generic Name
- Skin marking guide, single-use FDA UDI
- Device Name
- MediView Triangle Template Kit for use with the XR90 system. FDA UDI
- Model / Reference
- XR90-CT-KIT FDA UDI
- Description
- MediView Triangle Template Kit for use with the XR90 system. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850044606009 FDA UDI
- 510(k) Number
- K223125 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Skin marking guide, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Skin marking guide, single-use
Triangle Template Kit by MediView XR — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K223125 also covers:
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
- MediView XR
Sources (1)
- FDA UDI bf1cc02e-1ad8-4d44-9584-2a703d949f73 34 fields · synced Jun 9, 2026