Identity
- Trade Name
- Shoulder retr. for LEPS™ EUDAMEDShoulder retr. for LEPS™,set/2 FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- LEPS EUDAMEDShoulder retractor for use with LEPS, set of 2 FDA UDI
- Model / Reference
- 130350 EUDAMEDSHRT FDA UDI
- Description
- Shoulder retractor for use with LEPS, set of 2 FDA UDI
Identifiers
- Catalog Number
- 130350 FDA UDI
- Primary DI / UDI-DI
- 08719425702339 EUDAMEDFDA UDI
- Basic UDI-DI
- 872016816130300HB EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Indexed-immobilization patient positioning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Indexed-immobilization patient positioning system
Shoulder retr. for LEPS™, set/2 by Macromedics B.v. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- Macromedics B.v.
Sources (2)
- FDA UDI 7aa894ff-56eb-4c2e-b0c4-5a10f9b998ab 34 fields · synced Jul 23, 2026
- EUDAMED 6a38ae0b-bcf2-46ac-a53a-02b0a2b7acbd 61 fields · synced Jul 23, 2026