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Handle
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref MTGBSUB1Model Breast Positioning Devices
by Medtec LLC
Identity
- Trade Name
- Handle FDA UDI
- Generic Name
- Radiological arm/leg positioner FDA UDI
- Device Name
- Arm up T-grip positioner FDA UDI
- Model / Reference
- MTGBSUB1 EUDAMEDFDA UDIBreast Positioning Devices EUDAMED
- Description
- Arm up T-grip positioner FDA UDI
Identifiers
- Catalog Number
- MTGBSUB1 FDA UDI
- Primary DI / UDI-DI
- 00841439104194 EUDAMEDFDA UDI
- Basic UDI-DI
- 8414391OC0010R019Y EUDAMED
- 510(k) Number
- K973842 FDA UDI
- FDA Product Code
- IXQ 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
- 892.1980 FDA UDI
- Market of Registration
- Netherlands 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
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Length — 13.2 Inch FDA UDIWidth — 8.7 Inch FDA UDI
Category: Radiological arm/leg positioner
Handle by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Radiological arm/leg positioner.
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Cleared under the same submission
K973842 also covers:
- Body Pro-Lok™ Bridge — Medtec LLC
- Body Pro-Lok™ Platform — Medtec LLC
- Docking Station — Medtec LLC
- Docking Station — Medtec LLC
- IPPS™ Overlay — Medtec LLC
- IPPS™ Overlay — Medtec LLC
- IPPS™ Overlay — Medtec LLC
- IPPS™ Overlay — Medtec LLC
- IPPS™ Overlay — Medtec LLC
- Interface for Varian — Medtec LLC
- Interloc® Lok-Bar™ — Medtec LLC
- Patient Hand Grip — 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 4162e08a-264c-48bf-be6c-2e3e417d25e2 37 fields · synced Jun 19, 2026
- EUDAMED 51f813f3-9100-4937-8d7b-e79c5310176e 61 fields · synced Jun 19, 2026