Vacuum Cement Mixing Bowl 1400-2100

GUDID 25060238201920

SUMMIT MEDICAL LIMITED

Orthopaedic cement preparation/delivery kit
Primary Device ID25060238201920
NIH Device Record Key87e6b32d-97d7-4d0e-9c3e-44d8267cf60b
Commercial Distribution StatusIn Commercial Distribution
Brand NameVacuum Cement Mixing Bowl
Version Model Number1400-2100
Catalog Number1400-2100
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 Datetrue
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
Phone+441451821311
Emailinfo@summit-medical.co.uk
Phone+441451821311
Emailinfo@summit-medical.co.uk

Device Identifiers

Device Issuing AgencyDevice ID
GS115060238201923 [Primary]
GS125060238201920 [Package]
Contains: 15060238201923
Package: Carton [15 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 Date2025-11-26
Device Publish Date2025-11-18

Devices Manufactured by SUMMIT MEDICAL LIMITED

25060238201920 - Vacuum Cement Mixing Bowl2025-11-26
25060238201920 - Vacuum Cement Mixing Bowl2025-11-26
25060238201593 - Femoral Cement Pressuriser2025-01-20 Femoral Cement Pressuriser
25060238201630 - HiVac™ 7 Triple Mix 2025-01-20 HiVac™ 7 Triple Mix
25060238201654 - HiVac™ 7 with Femoral Cement Pressuriser 2025-01-20 HiVac™ 7 with Femoral Cement Pressuriser
25060238201678 - HiVac™ Syringe2025-01-20 HiVac™ Syringe
25060238201685 - HiVac™ Syringe2025-01-20 HiVac™ Syringe
25060238201715 - 9mm Nozzle With Nozzle Extruder2025-01-20 9mm Nozzle With Nozzle Extruder
25060238201722 - Quick-Vac® Vacuum Mixing Bowl2025-01-20 Quick-Vac® Vacuum Mixing Bowl
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.