Identity
- Trade Name
- PILLOW, GENTLETOUCH 5 INCH LT EUDAMEDFDA UDI
- Generic Name
- Freestanding headrest, single-use FDA UDI
- Device Name
- Operating Table Accessories EUDAMED
- Model / Reference
- 1941S EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 1941SDZ FDA UDI
- Primary DI / UDI-DI
- 00842430110092 EUDAMEDFDA UDI
- Basic UDI-DI
- 0842430158956Y EUDAMED
- FDA Product Code
- CCX FDA UDI
- EMDN Code
- Z12011285 PATIENT POSITIONING INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Freestanding headrest, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.6820 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Category: Freestanding headrest, single-use
Pillow, Gentletouch 5 Inch Lt 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
European Union Unknown
MDR
United States Pending data
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 8e2d7a41-7551-4d90-b13b-444edb6b831b 34 fields · synced Jun 19, 2026
- EUDAMED a3377381-aad3-4803-8b85-79c1d2f064c4 61 fields · synced Jun 14, 2026