Identity
- Trade Name
- Thermoplastic Mask FDA UDI
- Generic Name
- Patient positioning thermoplastic mould material FDA UDI
- Model / Reference
- MK8031 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815212022470 FDA UDI
- 510(k) Number
- K022708 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Patient positioning thermoplastic mould material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
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
Category: Patient positioning thermoplastic mould material
Thermoplastic Mask by Izi Medical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K022708 also covers:
- Thermoplastic Mask — IZI MEDICAL PRODUCTS LLC
- Thermoplastic Mask — IZI MEDICAL PRODUCTS LLC
- Thermoplastic Mask — IZI MEDICAL PRODUCTS LLC
- Thermoplastic Mask — IZI MEDICAL PRODUCTS LLC
- Thermoplastic Mask — IZI MEDICAL PRODUCTS LLC
- Thermoplastic Mask — IZI MEDICAL PRODUCTS LLC
- Thermoplastic Mask — IZI MEDICAL PRODUCTS LLC
- Thermoplastic Mask — IZI MEDICAL PRODUCTS LLC
- Thermoplastic Mask — IZI MEDICAL PRODUCTS LLC
- Thermoplastic Mask — IZI MEDICAL PRODUCTS LLC
- Thermoplastic Mask — IZI MEDICAL PRODUCTS LLC
- Thermoplastic Mask — IZI MEDICAL PRODUCTS LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Izi Medical Products Llc
Sources (1)
- FDA UDI 943825f5-d84c-4e21-8383-9b662e3a908d 33 fields · synced May 30, 2026