MiniMix LV SMLV

GUDID 25060238200749

Bone Cement Mixing System

SUMMIT MEDICAL LIMITED

Manual orthopaedic cement mixer, single-use
Primary Device ID25060238200749
NIH Device Record Key88be0d29-21c0-417d-bf07-ad7cff75c07f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiniMix LV
Version Model NumberSMLV
Catalog NumberSMLV
Company DUNS221751311
Company NameSUMMIT MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+441451821311
Emailinfo@summit-medical.co.uk
Phone+441451821311
Emailinfo@summit-medical.co.uk
Phone+441451821311
Emailinfo@summit-medical.co.uk
Phone+441451821311
Emailinfo@summit-medical.co.uk
Phone+441451821311
Emailinfo@summit-medical.co.uk
Phone+441451821311
Emailinfo@summit-medical.co.uk
Phone+441451821311
Emailinfo@summit-medical.co.uk
Phone+441451821311
Emailinfo@summit-medical.co.uk
Phone+441451821311
Emailinfo@summit-medical.co.uk

Device Identifiers

Device Issuing AgencyDevice ID
GS115060238200742 [Primary]
GS125060238200749 [Package]
Contains: 15060238200742
Package: Carton [10 Units]
In Commercial Distribution

FDA Product Code

JDZMixer, Cement, For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-07
Device Publish Date2019-10-30

Devices Manufactured by SUMMIT MEDICAL LIMITED

25060238201609 - 6mm Slim Flexible Nozzle2024-05-30 6mm Slim Flexible Nozzle
25060238201616 - HiVac™ 72024-05-28 Mixing and Delivery System
25060238201357 - SmartMix™ Vacuum Syringe2024-05-06 Bone cement mixing and delivery system
25060238201364 - SmartMix™ Vacuum Syringe Plus2024-05-06 Bone cement mixing and delivery system
25060238201371 - SmartMix™ Delivery Gun2024-05-06 Bone Cement Delivery Gun
25060238201418 - SmartMix™ Syringe Kit2024-05-06 Bone cement delivery system
25060238201586 - SmartMix™ 9mm Narrow Nozzle2024-05-06 9mm Narrow Straight Nozzle
15060238200148 - SmartMix Vacuum Footpump and Airhose 2023-02-17 SmartMix Vacuum Footpump and Airhose

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