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Immobilizer
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref MTDLIZ2Model Breast and Pelvis
by Medtec LLC
Identity
- Trade Name
- Immobilizer FDA UDI
- Generic Name
- Radiological arm/leg positioner FDA UDI
- Device Name
- dual low leg FDA UDI
- Model / Reference
- MTDLIZ2 EUDAMEDFDA UDIBreast and Pelvis EUDAMED
- Description
- dual low leg FDA UDI
Identifiers
- Catalog Number
- MTDLIZ2 FDA UDI
- Primary DI / UDI-DI
- 00841439111574 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621BREASTPELVISTG EUDAMED
- 510(k) Number
- K060737 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiological arm/leg positioner FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Dimensions & Sizes
- Size
- Length — 33.2 Inch FDA UDIWidth — 18.3 Inch FDA UDI
Category: Radiological arm/leg positioner
Immobilizer by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K060737 also covers:
- Arm Support — Medtec LLC
- Arm Support — Medtec LLC
- Arm Support — Medtec LLC
- Immobilizer — Medtec LLC
- MR Posi-S™ Adapter — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posifix® -2 Baseplate — Medtec LLC
- Posifix® Headrest — Medtec LLC
- Posifix® Headrest — Medtec LLC
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI 6044521b-bcfc-4d9a-9f66-51bd0e02bdf9 37 fields · synced Jul 30, 2026
- EUDAMED 7bdc43f1-89dc-4704-845b-f2cd66920074 61 fields · synced Jul 30, 2026