Identity
- Trade Name
- PALAMIX® FDA UDI
- Generic Name
- Manual orthopaedic cement mixer, single-use FDA UDI
- Device Name
- PALAMIX® is a vacuum mixing and application system for bone cements. It consists of: –PALAMIX® uno or PALAMIX® duo vacuum mixing system PALAMIX® uno and PALAMIX® duo allow for automatic collection of bone cement within the mixing cartridge under vacuum. FDA UDI
- Model / Reference
- UNO FDA UDI
- Description
- PALAMIX® is a vacuum mixing and application system for bone cements. It consists of: –PALAMIX® uno or PALAMIX® duo vacuum mixing system PALAMIX® uno and PALAMIX® duo allow for automatic collection of bone cement within the mixing cartridge under vacuum. FDA UDI
Identifiers
- Catalog Number
- 66057893 FDA UDI
- Primary DI / UDI-DI
- 04260102133587 FDA UDI
- FDA Product Code
- JDZ FDA UDI
- GMDN Term
- Manual orthopaedic cement mixer, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4210 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Manual orthopaedic cement mixer, single-use
Palamix® by Heraeus Medical LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Heraeus Medical LLC
Sources (1)
- FDA UDI a15a0f9a-543c-4e41-935b-b75fd98b5517 35 fields · synced May 30, 2026