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Groin Piece
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref MTPLVCSUB8Model Thermoplastic Devices
by Medtec LLC
Identity
- Trade Name
- Groin Piece FDA UDI
- Generic Name
- Radiological pelvis positioner FDA UDI
- Device Name
- (10 x 2.54cm) FDA UDI
- Model / Reference
- MTPLVCSUB8 EUDAMEDFDA UDIThermoplastic Devices EUDAMED
- Description
- (10 x 2.54cm) FDA UDI
Identifiers
- Catalog Number
- MTPLVCSUB8 FDA UDI
- Primary DI / UDI-DI
- 00841439107072 EUDAMEDFDA UDI
- Basic UDI-DI
- 8414391OC0003R01AA EUDAMED
- 510(k) Number
- K950866 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Radiological pelvis positioner FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 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
- Width — 1 Inch FDA UDILength — 4 Inch FDA UDI
Category: Radiological pelvis positioner
Groin Piece by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Radiological pelvis positioner.
- Qfix® MRI Pelvis System — Qfix · Class II
- Back/Abdomen SatPad™ — Sat Pad Inc. · Class II
- SofTouch™ — Qfix · Class II
- SofTouch™ Elite — Qfix · Class II
- MEDRAD® PRO-TEKT Endorectal Balloon — Bayer Medical Care Inc. · Class I
- Qfix® Carbon Fiber Pelvis System — Qfix · Class II
- Positioning Cushion — Medtec LLC · Class II
- HipFix® Baseplate — Medtec LLC · Class II
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 |
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Manufacturer
- Manufacturer
- Medtec LLC
Sources (2)
- FDA UDI 667fb0ad-c34d-45ea-99cb-ebbecdaf7081 38 fields · synced Jun 18, 2026
- EUDAMED 5c84f054-fdce-4205-990d-ee378efb3427 61 fields · synced Jun 18, 2026