FDA.reportPublic FDA data

MiniMix LV

Primary DI
15060238200742
Brand
MiniMix LV
Company
SUMMIT MEDICAL LIMITED
Model
SMLV
Catalog number
SMLV
Device description
Bone Cement Mixing System
Published
2019-10-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
25060238200749PackageGS110Not in Commercial Distribution
15060238200742PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2506023820074925060238200749
1506023820074215060238200742

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive manual orthopaedic cement preparation kit, single-useA collection of multiple hand-operated, noninvasive devices (supplied together and labelled as a single product), designed to mix polymethylmethacrylate (PMMA) powder with methylmethacrylate monomer 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 does not include patient-contact devices. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
221751311
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
true
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
15060238200155Prism II Ratchet Delivery Gun5401-35-0005401-35-0002022-12-09
15060238200162SmartMix Tower - Cement Delivery Gun5401-97-0005401-97-0002022-12-09
15060238200377Summit Medical Bone Cement Delivery GunH719H7192022-12-09
15060238200759MiniMix™ Delivery SyringeSMDS1C2021-12-01
15060238200995ClearMix Vacuum Mixing System Bone Cement Delivery Gun4147004147002022-12-09
15060238201374SmartMix™ Delivery Gun5401-76-5135401-76-5132024-04-26
15060238201787MiniMix™SMMM1SMMM12025-01-10
15060238201794MiniMix™ LVSMLVSMLV2025-01-10
15060238201800MiniMix™ Delivery SyringeSMDS1CSMDS1C2025-01-10
15060238201817Bone Cement Delivery GunH759H7592025-01-10
15060238201824Bone Cement Delivery GunH759LH759L2025-01-10
15060238201848Bone Cement Delivery GunH719H7192025-01-10
15060238200148SmartMix Vacuum Footpump and Airhose5401-96-5002023-02-09
15060238200254Summit Medical Bone Cement Ratchet Delivery GunH759H7592023-02-09
15060238200261Summit Medical Bone Cement Ratchet Delivery GunH759LH759L2023-02-09
15060238200278Summit Medical High Vacuum Footpump + Air HoseH550H5502023-02-09
15060238200452SmartMix CemVac Dual Vacuum Footpump & Airhose321002632100262023-02-09
15060238200735MiniMix™ Bone Cement/Substitute Mixing SystemSMMM1N/A2021-12-01
15060238201923Vacuum Cement Mixing Bowl1400-21001400-21002025-11-18
25060238201920Vacuum Cement Mixing Bowl1400-21001400-21002025-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456203163JMUJMU DENTAL, INCJDZ2026-08-18
00840456207123JMUJMU DENTAL, INCJDZ2026-08-18
00840456207130JMUJMU DENTAL, INCJDZ2026-08-18
00840456223628JMUJMU DENTAL, INCJDZ2026-08-18
00840456223635JMUJMU DENTAL, INCJDZ2026-08-18
00840456223642JMUJMU DENTAL, INCJDZ2026-08-18
00840456223659JMUJMU DENTAL, INCJDZ2026-08-18
00840456223789JMUJMU DENTAL, INCJDZ2026-08-18
00840456223796JMUJMU DENTAL, INCJDZ2026-08-18
00840456223802JMUJMU DENTAL, INCJDZ2026-08-18
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
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
15060238201787MiniMix™SUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201794MiniMix™ LVSUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201886Mixing bowl, SpatulaSUMMIT MEDICAL LIMITEDJDZ2025-01-10