Identity
- Trade Name
- WRIST STRAP PAIR 107 EUDAMEDFDA UDI
- Generic Name
- Limb/torso/head restraint, reusable FDA UDI
- Device Name
- Operating table support accessories EUDAMEDOperating table accessory FDA UDI
- Model / Reference
- 100000107 EUDAMEDWRIST STRAP PAIR 107 FDA UDI
- Description
- Operating table accessory FDA UDI
Identifiers
- Catalog Number
- 100000107 FDA UDI
- Primary DI / UDI-DI
- 06438435001073 EUDAMEDFDA UDI
- Basic UDI-DI
- 64384350581S8 EUDAMED
- Direct Marketing DI
- 06438435001073 EUDAMED
- FDA Product Code
- FWZ FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Limb/torso/head restraint, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4950 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Wrist Strap Pair 107 by Merivaara Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 64384350581S8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Merivaara Corporation
- EUDAMED SRN
- FI-MF-000001175
Sources (2)
- EUDAMED 82b6d943-f5b2-480f-93e4-e90b116be35a 61 fields · synced Jul 9, 2026
- FDA UDI 1b74e6b4-668c-4069-bbed-1445a31a65c9 35 fields · synced May 30, 2026