Meridian VPS 52080

GUDID 05708932553759

Coloplast A/S

Vaginal speculum, single-use
Primary Device ID05708932553759
NIH Device Record Keydae42019-d974-4a49-9dec-2bb09121f928
Commercial Distribution StatusIn Commercial Distribution
Brand NameMeridian VPS
Version Model Number52080
Catalog Number52080
Company DUNS305524696
Company NameColoplast A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.

Device Identifiers

Device Issuing AgencyDevice ID
GS105708932553759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKFCannula, manipulator/injector, uterine

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-02
Device Publish Date2023-09-22

Devices Manufactured by Coloplast A/S

05708932556576 - Coloplast2024-09-02
03600040143117 - Porges Coloplast2024-08-30 X-FLOW® Prostatectomy catheter straight tip 3 way 30-50ml 100% silicone CH FR 18
03600040143247 - Porges Coloplast2024-08-30 X-FLOW® Prostatectomy catheter straight tip 3-way 30-50 ml 100% silicone CH FR 20
03600040143377 - Porges Coloplast2024-08-30 X-FLOW® Prostatectomy catheter straight tip 3-way 30-50 ml 100% silicone CH FR 22
03600040143506 - Porges Coloplast2024-08-30 X-FLOW® Prostatectomy catheter straight tip 3-way 30-50 ml 100% silicone CH FR 24
03600040143636 - Porges Coloplast2024-08-30 X-FLOW® Prostatectomy catheter Couvelaire tip 3-way 30-50 ml 100% silicone CH FR 18
03600040143728 - Porges Coloplast2024-08-30 X-FLOW® Prostatectomy catheter Couvelaire tip 3-way 30-50 ml 100% silicone CH FR 20
03600040143810 - Porges Coloplast2024-08-30 X-FLOW® Prostatectomy catheter Couvelaire tip 3-way 30-50 ml 100% silicone CH FR 22

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