FDA.reportPublic FDA data

PALAGUN®

Primary DI
06951233720842
Brand
PALAGUN®
Company
Guangzhou Clean Medical Products Manufacturing Corp.
Model
CL006-02E(CM194)
Catalog number
CL006-02E(CM194)
Device description
PALAGUN® Bone Cement Mixing System - Disposable Cement Gun [Model NO.:CL006-02]
Published
2025-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
06951233720842PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06951233720842069512337208426951233720842

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529707388
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06951233721610CLEANESTCL006-06A1-02E2024-05-15
06951233721634CLEANESTCL006-06A2-01E2024-05-15
06951233721658CLEANESTCL006-06A2-02E2024-05-15
06951233721665CLEANESTCL006-06B1-01E2024-05-15
06951233721672CLEANESTCL006-06B1-02E2024-05-15
06951233721696CLEANESTCL006-06B2-01E2024-05-15
06951233721719CLEANESTCL006-06B2-02E2024-05-15
06951233721726CLEANESTCL006-06C1-01E2024-05-15
06951233721733CLEANESTCL006-06C1-02E2024-05-15
06951233721757CLEANESTCL006-06C2-01E2024-05-15
06951233721771CLEANESTCL006-06C2-02E2024-05-15
06951233721788CLEANESTCL006-06-17E2024-05-15
06951233721795CLEANESTCL006-06-18E2024-05-15
06951233721603CLEANESTCL006-06A1-01E2024-05-13
04260102136038HeraeusCL006-01-18(CM194)CL006-01-18(CM194)2024-04-11
06951233720125CLEANESTW-202-B(EC)W-202-B(EC)2024-04-11
06951233720170CLEANESTW-202-P3(EC)W-202-P3(EC)2024-04-11
06951233720316CLEANESTW-202-P4(EC)W-202-P4(EC)2024-04-11
06951233720330CLEANESTW-202-P11(EC)W-202-P11(EC)2024-04-11
06951233720361CLEANESTW-202-P1(EC)W-202-P1(EC)2024-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08031497003689Mendec® Kypho Set Monolateral 10 mmTECRES SPAKIH2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmTECRES SPAKIH2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmTECRES SPAKIH2025-12-17
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
06923558509693Kyphoplasty Tool KitJiangsu Changmei Medtech Co., Ltd.KIH2025-10-23
08053617184450PressurizerADLER ORTHO SPAKIH2025-10-07
08053617184467PressurizerADLER ORTHO SPAKIH2025-10-07
08053617184474PressurizerADLER ORTHO SPAKIH2025-10-07
08053617184481PressurizerADLER ORTHO SPAKIH2025-10-07
08053617183750PressurizerADLER ORTHO SPAKIH2025-08-07
08053617183767PressurizerADLER ORTHO SPAKIH2025-08-07
08053617183774PressurizerADLER ORTHO SPAKIH2025-08-07
08053617183781PressurizerADLER ORTHO SPAKIH2025-08-07
08053617183798PressurizerADLER ORTHO SPAKIH2025-08-07
08053617183804PressurizerADLER ORTHO SPAKIH2025-08-07
08053617184498PressurizerADLER ORTHO SPAKIH2025-08-07
00763000883461N/aMEDTRONIC SOFAMOR DANEK, INC.KIH2025-06-01
00763000883478N/aMEDTRONIC SOFAMOR DANEK, INC.KIH2025-06-01
00763000883485N/aMEDTRONIC SOFAMOR DANEK, INC.KIH2025-06-01
00763000242510MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.KIH2025-05-11
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
15060238201688HiVac™ SyringeSUMMIT MEDICAL LIMITEDKIH2025-01-10
150602382017189mm Nozzle With Nozzle ExtruderSUMMIT MEDICAL LIMITEDKIH2025-01-10
15060238201770Cement Mixing and Delivery SystemSUMMIT MEDICAL LIMITEDKIH2025-01-10
15060238201800MiniMix™ Delivery SyringeSUMMIT MEDICAL LIMITEDKIH2025-01-10