FDA.reportPublic FDA data

PALAMIX®

Primary DI
04260102131231
Brand
PALAMIX®
Company
Heraeus Medical GmbH
Model
Vacuum Pump
Catalog number
66036748
Device description
Reusable vacuum pump with one-way valve to use together with PALAMIX for mixing under vacuum
Published
2019-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JDYEvacuator, Vapor, Cement Monomer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDYEvacuator, Vapor, Cement MonomerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260102131231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260102131231042601021312314260102131231

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic material preparation vacuum pumpA pneumatically-powered device intended to create negative pressure (vacuum) during orthopaedic cement/filler mixing to help improve the quality of the resulting cement/filler (e.g., reduced porosity and fatigue). It is typically a portable unit containing a pump with a pressure dial/display and control(s), and is usually used in conjunction with an orthopaedic cement-mixing container and fume evacuation/filtering devices.

Regulatory Flags#

DUNS number
333623937
Device count
1
Premarket exempt
true
Serial number
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842962102091HNM MEDICALHNM STAINLESS, LLC.JDY2023-05-27
00842962104309HNM MEDICALHNM STAINLESS, LLC.JDY2023-05-27
15060238200148SmartMix Vacuum Footpump and Airhose SUMMIT MEDICAL LIMITEDJDY2023-02-09
15060238200278Summit Medical High Vacuum Footpump + Air HoseSUMMIT MEDICAL LIMITEDJDY2023-02-09
15060238200452SmartMix CemVac Dual Vacuum Footpump & Airhose SUMMIT MEDICAL LIMITEDJDY2023-02-09
04260056881022EASYMIX® compressed air hoseOSARTIS GmbHJDY2022-12-01
04260056881039EASYMIX® compressed air hoseOSARTIS GmbHJDY2022-12-01
04260056881633EASYMIX® vacuum pump IOSARTIS GmbHJDY2022-12-01
04260056881930EASYMIX® vacuum pump IIOSARTIS GmbHJDY2022-12-01
00889024374904NAZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.JDY2021-03-03
00889024374867NAZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.JDY2019-03-08
00889024374874NAZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.JDY2019-03-08
00889024374881NAZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.JDY2019-03-08
00889024374898NAZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.JDY2019-03-08
00889024376670Miller™Zimmer, Inc.JDY2016-10-10
00889024382107Miller™Zimmer, Inc.JDY2016-10-10