FDA.reportPublic FDA data

MiniMix™ LV

Primary DI
15060238201794
Brand
MiniMix™ LV
Company
SUMMIT MEDICAL LIMITED
Model
SMLV
Catalog number
SMLV
Device description
MiniMix™ LV
Published
2025-01-10
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

Contact Domains#

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
25060238201791PackageGS110In Commercial Distribution
15060238201794PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2506023820179125060238201791
1506023820179415060238201794

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+441451821311info@summit-medical.co.uk

Regulatory Flags#

DUNS number
221751311
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060238201923Vacuum Cement Mixing Bowl1400-21001400-21002025-11-18
25060238201920Vacuum Cement Mixing Bowl1400-21001400-21002025-11-18
15060238201138CellTrans ABT45102018-12-21
15060238201329Spatula & Curette PackSC012022-08-23
15060238201596Femoral Cement PressuriserP721P7212025-01-10
15060238201633HiVac™ 7 Triple Mix C703C7032025-01-10
15060238201657HiVac™ 7 with Femoral Cement Pressuriser CP701CP7012025-01-10
15060238201671HiVac™ SyringeS727S7272025-01-10
15060238201688HiVac™ SyringeS717WS717W2025-01-10
150602382017189mm Nozzle With Nozzle ExtruderN700N7002025-01-10
15060238201725Quick-Vac® Vacuum Mixing Bowl00504900100005049001002025-01-10
15060238201732Quick-Vac® Vacuum Mixing Bowl00504900115005049001152025-01-10
15060238201749HiVac BowlB713B7132025-01-10
15060238201756Rally™ Vacuum Mixing Bowl7127-18017127-18012025-01-10
15060238201770Cement Mixing and Delivery System00-4501-090-0000-4501-090-002025-01-10
15060238201787 MiniMix™SMMM1SMMM12025-01-10
15060238201800MiniMix™ Delivery SyringeSMDS1CSMDS1C2025-01-10
15060238201886Mixing bowl, SpatulaB710B7102025-01-10
25060238201593Femoral Cement PressuriserP721P7212025-01-10
25060238201630HiVac™ 7 Triple Mix C703C7032025-01-10

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
04250203943482QuattroMixJoline GmbH & Co. KGJDZ2026-03-03
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
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