Identity
- Trade Name
- O.D.I. Checking Tool FDA UDI
- Generic Name
- Multi-modality therapeutic radiation phantom, test object FDA UDI
- Device Name
- Reusable non-sterile optical distance indicator for use with Iso-Align FDA UDI
- Model / Reference
- MTIAD16 FDA UDI
- Description
- Reusable non-sterile optical distance indicator for use with Iso-Align FDA UDI
Identifiers
- Catalog Number
- MTIAD16 FDA UDI
- Primary DI / UDI-DI
- 00841439104378 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
- Not 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
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 1.97 Inch FDA UDILength — 7.87 Inch FDA UDI
O.D.I. Checking Tool by Medtec 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
- Medtec LLC
Sources (1)
- FDA UDI f9399218-47d7-41ff-9872-2503103569f7 37 fields · synced Jun 8, 2026