Identity
- Trade Name
- Iso-Point FDA UDI
- Generic Name
- Multi-modality therapeutic radiation phantom, test object FDA UDI
- Device Name
- Rotational runout tool for use with Iso-Align™ FDA UDI
- Model / Reference
- MTIAD100 FDA UDI
- Description
- Rotational runout tool for use with Iso-Align™ FDA UDI
Identifiers
- Catalog Number
- MTIAD100 FDA UDI
- Primary DI / UDI-DI
- 00841439104361 FDA UDI
- FDA Product Code
- LHO FDA UDI
- GMDN Term
- Multi-modality therapeutic radiation phantom, test object FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1940 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
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 26 Centimeter FDA UDIWidth — 13 Centimeter FDA UDI
Category: Multi-modality therapeutic radiation phantom, test object
Iso-Point by Medtec LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Medtec LLC
Sources (1)
- FDA UDI af05a3fe-4342-41d1-9887-b0c8af46fcab 36 fields · synced May 30, 2026