FDA.reportPublic FDA data

MiniMix™ Delivery Syringe

Primary DI
15060238201800
Brand
MiniMix™ Delivery Syringe
Company
SUMMIT MEDICAL LIMITED
Model
SMDS1C
Catalog number
SMDS1C
Device description
MiniMix™ Delivery Syringe
Published
2025-01-10
Public version status
Update
Distribution status
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
KIHDispenser, Cement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIHDispenser, CementOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
25060238201807PackageGS110In Commercial Distribution
15060238201800PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2506023820180725060238201807
1506023820180015060238201800

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantable material dispenser, reservoir-containingA non-powered, syringe-/pipette-like device intended to load orthopaedic cement and/or a bone void filling material (not included) within an included reservoir/barrel and dispense the material during surgery. It is not designed to accept a separate cartridge/syringe or prepare/mix the substance. It may be intended to be manually-operated or mounted in a powered unit that drives the piston down the syringe barrel. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

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
15060238200742MiniMix LVSMLVSMLV2019-10-30
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
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
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
06951233720842PALAGUN®Guangzhou Clean Medical Products Manufacturing Corp.KIH2025-06-05
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