FDA.reportPublic FDA data

QuattroMix

Primary DI
04250203943482
Brand
QuattroMix
Company
Joline GmbH & Co. KG
Model
US9620
Published
2026-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDZMixer, Cement, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDZMixer, Cement, For Clinical UseOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250203943482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250203943482042502039434824250203943482

GMDN Terms#

Term, Definition table
TermDefinition
Manual orthopaedic cement mixer, single-useA sterile hand-operated device designed to mix polymethylmethacrylate (PMMA) powder with methylmethacrylate monomer in order to produce polymerizing bone cement. It typically consists of a vessel with attached/attachable mixing blades where the cement is mixed. It may include a plunger unit used to transfer the mixed cement from the vessel into an applicator prior to the surgical procedure, and a suction tube to enable connection to a separate fume extraction device. It is typically operated outside of the sterile surgical field and is not intended to contact the patient. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
342087108
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
04250203940399Best Kit Stop'n GO 2 x 8 mmUS7OA22002020-08-14
04250203940405Best Kit Mod. One Pedicle Stop'n GO 2 x 8 mmUS7ON12002020-08-14
04250203940436Best Kit SpeedTrack Stop'n GO 2 x 8 mmUS7OS22002020-08-14
04250203940443Best Kit RapidIntro Bevel Tip Stop'n GO 2 x 8 mmUS7OR22002020-08-14
04250203940450Best Kit Stop'n GO 2 x 8 mmUS7HA22002020-08-14
04250203940467Best Kit SpeedTrack Stop'n GO 2 x 8 mmUS7HS22002020-08-14
04250203940474Best Kit RapidIntro Bevel Tip Stop'n GO 2 x 8 mmUS7HR22002020-08-14
04250203940481Best Kit Mod. One Pedicle Stop'n GO 2 x 8 mmUS7HN12002020-08-14
04250203940535Best Kit 16/16US7OA21102020-08-14
04250203940542Best Kit 22/16US7OA21202020-08-14
04250203940559Best Kit 16/16US7HA21102020-08-14
04250203940566Best Kit 22/16US7HA21202020-08-14
04250203940733Vertebra Access Device with Bevel Tip Needle & StyletUS91042020-08-14
04250203940771RapidIntro Trocar Tip Introducer Cannula & StyletUS92112020-08-14
04250203940498Smart Kit Stop'n GO 2 x 8 mmUS7NA22002020-08-14
04250203940504Smart Kit SpeedTrack Stop'n GO 2 x 8 mmUS7NS22002020-08-14
04250203940511Smart Kit RapidIntro Bevel Tip Stop'n GO 2 x 8 mmUS7NR22002020-08-14
04250203940528Smart Kit Mod. One Pedicle Stop'n GO 2 x 8 mmUS7NN12002020-08-14
04250203940573Smart Kit 16/16US7NA21102020-08-14
04250203940580Smart Kit 22/16US7NA21202020-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D125705550R4Premium PlusPremium Plus (Dongguan) LimitedJDZ2026-05-20
D125705550W4Premium PlusPremium Plus (Dongguan) LimitedJDZ2026-05-20
06934415056632ZKSKBeijing ZKSK Technology Co.,LtdJDZ2026-05-18
06934415056649ZKSKBeijing ZKSK Technology Co.,LtdJDZ2026-05-18
03701505801211DynamoTEKNIMEDJDZ2026-02-02
03701505801228DynamoTEKNIMEDJDZ2026-02-02
03701505801235DynamoTEKNIMEDJDZ2026-02-02
15060238201923Vacuum Cement Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-11-18
25060238201920Vacuum Cement Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-11-18
03701505801020PureKit Syringe 1.5cc MVTEKNIMEDJDZ2025-03-31
03701505801037META+ System 1.5cc MVTEKNIMEDJDZ2025-03-31
03701505801075PUREKIT SyringesTEKNIMEDJDZ2025-03-31
03701505800498PureKit Syringe 4cc MVTEKNIMEDJDZ2025-03-31
15060238201725Quick-Vac® Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201732Quick-Vac® Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201749HiVac BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201756Rally™ Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201787 MiniMix™SUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201794MiniMix™ LVSUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201886Mixing bowl, SpatulaSUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201722Quick-Vac® Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201739Quick-Vac® Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201746HiVac BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201753Rally™ Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201784 MiniMix™SUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201791MiniMix™ LVSUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201883Mixing bowl, SpatulaSUMMIT MEDICAL LIMITEDJDZ2025-01-10
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONJDZ2024-11-21
07613327547535AutoPlex M4STRYKER CORPORATIONJDZ2024-11-21
08058964723758Disp. Mixing Bowl-OG21 SRLJDZ2024-10-14