Identity
- Trade Name
- SLING, REHAB SHOULDER, ABDUCTION EUDAMEDFDA UDI
- Generic Name
- Shoulder immobilizer/orthosis, single-use FDA UDI
- Device Name
- Operating Table Accessories EUDAMED
- Model / Reference
- 867 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 867 FDA UDI
- Primary DI / UDI-DI
- 00842430115097 EUDAMEDFDA UDI
- Basic UDI-DI
- 0842430158956Y EUDAMED
- FDA Product Code
- ILI FDA UDI
- EMDN Code
- Z12011285 PATIENT POSITIONING INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Shoulder immobilizer/orthosis, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3640 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Shoulder immobilizer/orthosis, single-use
Sling, Rehab Shoulder, Abduction by Mizuho Orthopedic Systems, Inc. — Class I — 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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mizuho Orthopedic Systems, Inc.
Sources (2)
- FDA UDI 376539e2-ccff-443d-9163-20ee9fb2e5ed 34 fields · synced Jul 9, 2026
- EUDAMED ac210ecb-6084-4238-9725-31d5c14991d6 61 fields · synced Jul 9, 2026