FDA.reportPublic FDA data

PALAGUN®

Primary DI
06951233720842
Brand
PALAGUN®
Company
Guangzhou Clean Medical Products Manufacturing Corp.
Model
CL006-02E(CM194)
Catalog number
5082371
Device description
PALAGUN® Bone Cement Mixing System - Disposable Cement Gun (Model No.: CL006-02)
Published
2025-06-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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.

Regulatory Flags#

DUNS number
529707388
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06951233720644EASYMIX® bowlLD2000LD20002022-12-12
06951233721610CLEANESTCL006-06A1-02ECL006-06A1-02E2024-05-15
06951233721634CLEANESTCL006-06A2-01ECL006-06A2-01E2024-05-15
06951233721658CLEANESTCL006-06A2-02ECL006-06A2-02E2024-05-15
06951233721665CLEANESTCL006-06B1-01ECL006-06B1-01E2024-05-15
06951233721672CLEANESTCL006-06B1-02ECL006-06B1-02E2024-05-15
06951233721696CLEANESTCL006-06B2-01ECL006-06B2-01E2024-05-15
06951233721719CLEANESTCL006-06B2-02ECL006-06B2-02E2024-05-15
06951233721726CLEANESTCL006-06C1-01ECL006-06C1-01E2024-05-15
06951233721733CLEANESTCL006-06C1-02ECL006-06C1-02E2024-05-15
06951233721757CLEANESTCL006-06C2-01ECL006-06C2-01E2024-05-15
06951233721771CLEANESTCL006-06C2-02ECL006-06C2-02E2024-05-15
06951233721788CLEANESTCL006-06-17ECL006-06-17E2024-05-15
06951233721795CLEANESTCL006-06-18ECL006-06-18E2024-05-15
06951233721603CLEANESTCL006-06A1-01ECL006-06A1-01E2024-05-13
04260102136038HeraeusCL006-01-18(CM194)50763732024-04-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150081073Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.KIH2026-07-30
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