FDA.reportPublic FDA data

PALAMIX®

Primary DI
04260102131170
Brand
PALAMIX®
Company
Heraeus Medical GmbH
Model
Cement gun
Catalog number
66036163
Device 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.
Published
2018-03-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KIHDispenser, Cement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIHDispenser, CementOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260102131170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260102131170042601021311704260102131170

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement/bone filler dispensing gunA hand-operated device designed to hold an orthopaedic cement/filler syringe/cartridge and to facilitate the dispensing of the substance to the application site or an application device. It is a pistol-like device with a barrel recess, to place the syringe/cartridge, which includes a trigger mechanism to force the substance from the distal end, and may include graduated markings to dispense the substance in discrete quantities. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
333623937
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260102133044COPAL® exchange GTrial Set knee50926072020-07-07
04260102139329COPAL® knee mould Trial M USM51659232023-06-25
04260102139350COPAL® knee mould Trial L USL51659242023-06-25
04260102139381COPAL® knee mould Trial S USS51598742023-06-25
04260102139411OSTEOPAL®V51309822025-09-26
04260102139428OSTEOPAL®V51309822025-09-26
04260102139855COPAL® G+V1x4051842672024-06-10
04260102139862COPAL® G+V1x4051842672024-06-10
04260102136670COPAL® exchange Ghip S long50347922019-11-25
04260102136700COPAL® exchange Ghip M long50347902019-11-25
04260102136731COPAL® exchange G hip L long50347852019-11-25
04260102136762COPAL® exchange Ghip XL long50347942019-11-25
04260102136793COPAL® exchange Ghip S short50347932019-11-25
04260102136823COPAL® exchange Ghip M short50347912019-11-25
04260102136854COPAL® exchange Ghip L short50347882019-11-25
04260102139176COPAL® exchange Ghip S medium51472152022-05-15
04260102139206COPAL® exchange Ghip M medium51472162022-05-15
04260102136885COPAL® exchange Ghip XL short50347952019-11-25
04260102136694COPAL® exchange Ghip S long50347922019-11-25
04260102136724COPAL® exchange Ghip M long50347902019-11-25

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Primary DI, Brand, Company table
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08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAKIH2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmTECRES SPAKIH2025-12-17
08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAKIH2025-12-17
06923558507569Kyphoplasty Tool KitJiangsu Changmei Medtech Co., Ltd.KIH2025-10-23
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15060238201633HiVac™ 7 Triple Mix SUMMIT MEDICAL LIMITEDKIH2025-01-10
15060238201657HiVac™ 7 with Femoral Cement Pressuriser SUMMIT MEDICAL LIMITEDKIH2025-01-10
15060238201671HiVac™ SyringeSUMMIT MEDICAL LIMITEDKIH2025-01-10
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150602382017189mm Nozzle With Nozzle ExtruderSUMMIT MEDICAL LIMITEDKIH2025-01-10