Pillow, Gentletouch, 5 Inch Rt
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- PKIT, RWF, 7" GENTLETOUCH PILLOW EUDAMEDPILLOW, GENTLETOUCH 6 INCH RT EUDAMEDPILLOW, GENTLETOUCH, 5 INCH RT FDA UDIPILLOW, GENTLETOUCH, 7 INCH RT FDA UDI
- Generic Name
- Freestanding headrest, single-use FDA UDI
- Device Name
- Operating Table Accessories EUDAMED
- Model / Reference
- 1937S EUDAMEDFDA UDI1937 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 1937SDZ FDA UDI1937DZ FDA UDI
- Primary DI / UDI-DI
- 00842430110115 EUDAMEDFDA UDI00842430101748 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
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: Freestanding headrest, single-use
Pillow, Gentletouch, 5 Inch Rt 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 (4)
- FDA UDI d41d8766-c8a9-46c6-a348-49b91a615bce 34 fields · synced Jul 18, 2026
- FDA UDI 8f5083a2-cd9c-43f6-ac4e-6e3869e538b1 34 fields · synced May 30, 2026
- EUDAMED 0b90ff80-0bd2-47c4-94c4-e53c0916940e 61 fields · synced Jun 19, 2026
- EUDAMED 7753a005-7d6c-4480-81eb-9a780f0d7712 61 fields · synced Jul 18, 2026