Identity
- Trade Name
- PALAMIX® FDA UDI
- Generic Name
- Orthopaedic cement dispenser FDA UDI
- Device Name
- The PALAMIX® cement gun is intended to accommodate the mixing cartridges of the PALAMIX® vacuum mixing system or the PALACOS® R+G pro and then to ensure precise and effortless application of bone cement. The trigger of the PALAMIX® cement gun is operated by hand to expel the bone cement from the mixing cartridge. Activating the trigger advances the feed rod in the mixing cartridge and expels the bone cement under high pressure. The PALAMIX® cement gun can only be used in conjunction with the PALAMIX® vacuum mixing system or PALACOS® R+G pro. FDA UDI
- Model / Reference
- Cement gun FDA UDI
- Description
- The PALAMIX® cement gun is intended to accommodate the mixing cartridges of the PALAMIX® vacuum mixing system or the PALACOS® R+G pro and then to ensure precise and effortless application of bone cement. The trigger of the PALAMIX® cement gun is operated by hand to expel the bone cement from the mixing cartridge. Activating the trigger advances the feed rod in the mixing cartridge and expels the bone cement under high pressure. The PALAMIX® cement gun can only be used in conjunction with the PALAMIX® vacuum mixing system or PALACOS® R+G pro. FDA UDI
Identifiers
- Catalog Number
- 66036163 FDA UDI
- Primary DI / UDI-DI
- 04260102131170 FDA UDI
- FDA Product Code
- KIH FDA UDI
- GMDN Term
- Orthopaedic cement dispenser FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic cement dispenser
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 9b0f28f7-67df-4c0f-94a9-5fd93cfd67e7 35 fields · synced May 30, 2026