10732ROI Dual Tip Skin Mrkr; Reg/Fine Skin Mrkr Gentian Vlt; w/Ruler/Label; PL 10732ROI

GUDID 20787551008535

10732ROI Dual Tip Skin Marker; Regular and Fine Tip Skin Marker Gentian Violet; w/ Ruler and Labels; PL

XODUS MEDICAL, INC.

Skin marking pen, single-use
Primary Device ID20787551008535
NIH Device Record Key4767a642-8960-44d4-b47e-08a9724a842e
Commercial Distribution StatusIn Commercial Distribution
Brand Name10732ROI Dual Tip Skin Mrkr; Reg/Fine Skin Mrkr Gentian Vlt; w/Ruler/Label; PL
Version Model Number10732ROI
Catalog Number10732ROI
Company DUNS868042664
Company NameXODUS MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(724)337-5500
Emailplloyd@xodusmedical.com
Phone+1(724)337-5500
Emailplloyd@xodusmedical.com
Phone+1(724)337-5500
Emailplloyd@xodusmedical.com
Phone+1(724)337-5500
Emailplloyd@xodusmedical.com
Phone+1(724)337-5500
Emailplloyd@xodusmedical.com
Phone+1(724)337-5500
Emailplloyd@xodusmedical.com
Phone+1(724)337-5500
Emailplloyd@xodusmedical.com
Phone+1(724)337-5500
Emailplloyd@xodusmedical.com
Phone+1(724)337-5500
Emailplloyd@xodusmedical.com
Phone+1(724)337-5500
Emailplloyd@xodusmedical.com
Phone+1(724)337-5500
Emailplloyd@xodusmedical.com
Phone+1(724)337-5500
Emailplloyd@xodusmedical.com
Phone+1(724)337-5500
Emailplloyd@xodusmedical.com
Phone+1(724)337-5500
Emailplloyd@xodusmedical.com
Phone+1(724)337-5500
Emailplloyd@xodusmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100787551008531 [Primary]
GS120787551008535 [Package]
Contains: 00787551008531
Package: CASE [100 Units]
In Commercial Distribution

FDA Product Code

FZZMARKER, SKIN

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20787551008535]

Radiation Sterilization


[20787551008535]

Radiation Sterilization


[20787551008535]

Radiation Sterilization


[20787551008535]

Radiation Sterilization


[20787551008535]

Radiation Sterilization


[20787551008535]

Radiation Sterilization


[20787551008535]

Radiation Sterilization


[20787551008535]

Radiation Sterilization


[20787551008535]

Radiation Sterilization


[20787551008535]

Radiation Sterilization


[20787551008535]

Radiation Sterilization


[20787551008535]

Radiation Sterilization


[20787551008535]

Radiation Sterilization


[20787551008535]

Radiation Sterilization


[20787551008535]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-10-17
Device Publish Date2022-12-13

Devices Manufactured by XODUS MEDICAL, INC.

20787551011917 - 10203 Coated Ruler Printed2024-09-11 10203 Coated Ruler Printed
20787551011931 - NS10203 Coated Ruler Printed #4000 8PT C1S2024-09-11 NS10203 Coated Ruler Printed #4000 8PT C1S
20787551006104 - 50300 EZ Cover Foot Pedal Bag w/ Large Button2024-07-25 50300 EZ Cover Foot Pedal Bag w/ Large Button
20787551039744 - 40680 The Pink Pad - Advanced Trendelenburg Positioning Kit - Biodegradable2024-07-25 40680 The Pink Pad - Advanced Trendelenburg Positioning Kit - Biodegradable
20787551040696 - SPK10251 Specialty Positioning Kit2024-07-25 SPK10251 Specialty Positioning Kit
20787551040702 - NSCL25278 Custom Med Label Pack2024-07-25 NSCL25278 Custom Med Label Pack
20787551040719 - SPK11538 Surgical BackPack Kit2024-07-25 SPK11538 Surgical BackPack Kit
20787551040726 - RTK10562 Room Turn-Over Kit2024-07-25 RTK10562 Room Turn-Over Kit

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