Identity
- Trade Name
- Thermoplastic Frame FDA UDI
- Generic Name
- Patient positioner base plate FDA UDI
- Device Name
- Stereotactic frame FDA UDI
- Model / Reference
- MTSNT3 FDA UDI
- Description
- Stereotactic frame FDA UDI
Identifiers
- Catalog Number
- MTSNT3 FDA UDI
- Primary DI / UDI-DI
- 00841439107744 FDA UDI
- FDA Product Code
- IYE FDA UDILNH FDA UDI
- GMDN Term
- Patient positioner base plate FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI892.1000 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Length — 10.5 Inch FDA UDIWidth — 9.4 Inch FDA UDI
Category: Patient positioner base plate
Thermoplastic Frame by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient positioner base plate.
- Meicen — Guangdong Meicen Medical Equipment Co., Ltd. · Class I
- SRS MR Adapter — Qfix · Class II
- Alta — Qfix · Class II
- Arthrex TRIMANO quick adapter — Maquet, Inc. · Class I
- SRS Adapter — Qfix · Class II
- kVue™ BoS™ — Qfix · Class II
- Adapter TRIMANO FORTIS — Maquet, Inc. · Class I
- TRIMANO FORTIS — Maquet, Inc. · Class I
Cleared under the same submission
K080072 also covers:
- Elekta Unity Lok-Bar™ — Medtec LLC
- Elekta Unity QA Lok-Bar™ — Medtec LLC
- Headrest — Medtec LLC
- Headrest — Medtec LLC
- Headrest - TIMO Size A, B, C, F — Medtec LLC
- Headrest - Timo size F with base — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- IPPS™ Overlay — Medtec LLC
- Slide Guide 3-Pin Lok-Bar™ — Medtec LLC
- Thermoplastic Frame — Medtec LLC
- Type-S™ Thermoplastic — Medtec LLC
- Type-S™ Thermoplastic — Medtec LLC
K093738 also covers:
- AccuForm™ Cushion — Medtec LLC
- Headrest - TIMO Size A, B, C, F — Medtec LLC
- Headrest - Timo size F with base — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- MR Posi-S™ Adapter — Medtec LLC
- Monarch™ Overhead Arm Positioner — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posifix® Headrest — Medtec LLC
K933227 also covers:
- Fixator™ — Medtec LLC
- Fixator™ Shoulder Cups — Medtec LLC
- Headrest — Medtec LLC
- Headrest — Medtec LLC
- Headrest — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- MR Posi-S™ Adapter with Backplate — Medtec LLC
- Prone Face Cushion — Medtec LLC
- Shim — Medtec LLC
- Shim — Medtec 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
- Medtec LLC
Sources (1)
- FDA UDI a37aeddd-d114-4146-a969-f9305583fd6b 37 fields · synced May 30, 2026