Identity
- Trade Name
- PALAMIX® FDA UDI
- Generic Name
- Orthopaedic cement dispenser FDA UDI
- Device Name
- PALAMIX® nozzles are available in different lengths and diameters for applying bone cement pre-mixed by the PALAMIX® uno or PALAMIX® duo vacuum mixing system. PALAMIX® nozzle medium is the accessory of PALAMIX® uno or PALAMIX® duo vacuum mixing system intended for use in placing bone cement into surgical sites. FDA UDI
- Model / Reference
- Nozzle Medium FDA UDI
- Description
- PALAMIX® nozzles are available in different lengths and diameters for applying bone cement pre-mixed by the PALAMIX® uno or PALAMIX® duo vacuum mixing system. PALAMIX® nozzle medium is the accessory of PALAMIX® uno or PALAMIX® duo vacuum mixing system intended for use in placing bone cement into surgical sites. FDA UDI
Identifiers
- Catalog Number
- 66043960 FDA UDI
- Primary DI / UDI-DI
- 04260102132375 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
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: Orthopaedic cement dispenser
Palamix® by Heraeus Medical LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic cement dispenser.
- VertePort X4 Manifold — Stryker Corp. · Class I
- Kyphon® Multi-tap™ Adapter — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Graftgun Universal Graft Delivery System -Long Narrow Tip Adapter — SURGENTEC LLC · Class II
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- CarboClear Pedicle Screw System — CARBOFIX ORTHOPEDICS LTD · Class II
- MiniMix™ Delivery Syringe — Summit Medical, LLC · Class I
- Vertebra Filler Device (Frontal Opening) — Joline GmbH & Co. KG · Class II
- KYPHON® Directional Bone Filler Device — MEDTRONIC SOFAMOR DANEK, INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Heraeus Medical LLC
Sources (1)
- FDA UDI 4ebbc4fd-546f-4f2c-91a3-29ee6c125883 35 fields · synced May 30, 2026