Pkit, Rwf, 7" Gt Pillow, Arm Cradles
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- PKIT, RWF,7" GT PILLOW, ARM CRADLES 1/EA EUDAMEDPKIT, RWF, 7" GT PILLOW, ARM CRADLES FDA UDI
- Generic Name
- Surgical linen/cushion set FDA UDI
- Device Name
- Operating Table Accessories EUDAMED
- Model / Reference
- 5322-1 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 5322 FDA UDI
- Primary DI / UDI-DI
- 00842430109058 EUDAMEDFDA UDI
- Basic UDI-DI
- 0842430158956Y EUDAMED
- FDA Product Code
- CCX FDA UDI
- EMDN Code
- Z12011285 PATIENT POSITIONING INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Surgical linen/cushion set 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: Surgical linen/cushion set
Pkit, Rwf, 7" Gt Pillow, Arm Cradles by Mizuho Orthopedic Systems, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical linen/cushion set.
- Bosma Enterprises — Bosma Enterprises · Class I
- Bosma Enterprises — Bosma Enterprises · Class I
- Clip-On™ Patient Protective Pads — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
- Bosma Enterprises — Bosma Enterprises · Class I
- Bosma Enterprises — Bosma Enterprises · Class I
- Bosma Enterprises — Bosma Enterprises · Class I
- Bosma Enterprises — Bosma Enterprises · Class I
- Bosma Enterprises — Bosma Enterprises · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mizuho Orthopedic Systems, Inc.
Sources (2)
- FDA UDI c60ad2f2-8b69-4768-bb26-eaf126632b1f 34 fields · synced Jun 19, 2026
- EUDAMED 90d1639f-a75e-4563-9efe-ca0bfee95546 61 fields · synced Jun 19, 2026