MED11180USA

GUDID 05060247262000

The PCF Pro Washer Disinfector Sonic Irrigation System will clean and thermally disinfect 60 lumen / robotic instruments in a single cycle.

MEDISAFE UK LIMITED

Surgical utensil washer/disinfector Surgical utensil washer/disinfector Surgical utensil washer/disinfector Surgical utensil washer/disinfector Surgical utensil washer/disinfector Surgical utensil washer/disinfector Surgical utensil washer/disinfector Surgical utensil washer/disinfector Surgical utensil washer/disinfector Surgical utensil washer/disinfector Surgical utensil washer/disinfector Surgical utensil washer/disinfector Surgical utensil washer/disinfector Surgical utensil washer/disinfector Surgical utensil washer/disinfector Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Surgical instrument washer/disinfector (chemical/thermal) Surgical instrument washer/disinfector (chemical/thermal) Surgical instrument washer/disinfector (chemical/thermal) Surgical instrument washer/disinfector (chemical/thermal) Surgical instrument washer/disinfector (chemical/thermal) Surgical instrument washer/disinfector (chemical/thermal) Surgical instrument washer/disinfector (chemical/thermal) Surgical instrument washer/disinfector (chemical/thermal) Surgical instrument washer/disinfector (chemical/thermal) Surgical instrument washer/disinfector (chemical/thermal) Surgical instrument washer/disinfector (chemical/thermal) Surgical instrument washer/disinfector (chemical/thermal) Surgical instrument washer/disinfector (chemical/thermal) Surgical instrument washer/disinfector (chemical/thermal) Surgical instrument washer/disinfector (chemical/thermal) Surgical instrument washer/disinfector (chemical/thermal) Surgical instrument washer/disinfector (chemical/thermal) Surgical instrument washer/disinfector (chemical/thermal)
Primary Device ID05060247262000
NIH Device Record Key3c1deaf3-bab3-488e-a298-d8b2ba0d9110
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberPCF PRO
Catalog NumberMED11180USA
Company DUNS505942961
Company NameMEDISAFE UK 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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com
Phone+1(999)999-9999
Emailinfo@medisafeinternational.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105060247262000 [Primary]

FDA Product Code

MECDisinfector, medical devices

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-28
Device Publish Date2016-09-16

Devices Manufactured by MEDISAFE UK LIMITED

00724995152727 - InnoWave2021-04-08 The InnoWave Ultra + Sonic Irrigator tabletop is designed to thoroughly clean (remove tissue, blood and other contaminants) from
00724995152734 - InnoWave2021-04-08 The InnoWave Ultra Sonic Irrigator tabletop is designed to thoroughly clean (remove tissue, blood and other contaminants) from a
00724995152758 - InnoWave2021-04-08 The InnoWave Eco Ultrasonic Cleaner (2.6 GAL) s designed to clean small surgical instruments with sonic cavitation technology wh
00724995152765 - InnoWave2021-04-08 The InnoWave Eco Ultrasonic Cleaner (5.3 GAL) s designed to clean small surgical instruments with sonic cavitation technology wh
00724995168681 - InnoWave2021-04-08 The InnoWave Unity Ultrasonic Irrigator is a freestanding ultrasonic cleaner that gives you powerful performance with exceptiona
00724995168698 - InnoWave2021-04-08 The InnoWave Unity Ultrasonic Irrigator is a freestanding ultrasonic cleaner that gives you powerful performance with exception
00724995193737 - InnoWave2021-04-08 The InnoWave Unity 20 Ultrasonic Irrigator is designed to process up to 16 lumened devices, or up to 35 lbs. per cycle of non-lu
55060247263194 - Distal Duck2021-04-08 Distal Duck Kit Point of Use Preparation keeps robotic and complex instruments moist during transportation to reduce the manual

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.