NS10411 Correct Site Marker; Sharpie Style; w/ Ruler and Labels NS10411

GUDID 20787551008719

NS10411 Correct Site Marker; Sharpie Style; w/ Ruler and Labels

XODUS MEDICAL, INC.

Skin marking pen, single-use Skin marking pen, single-use Skin marking pen, single-use Skin marking pen, single-use Skin marking pen, single-use Skin marking pen, single-use Skin marking pen, single-use Skin marking pen, single-use Skin marking pen, single-use Skin marking pen, single-use Skin marking pen, single-use Skin marking pen, single-use Skin marking pen, single-use Skin marking pen, single-use Skin marking pen, single-use
Primary Device ID20787551008719
NIH Device Record Keyf0df7a61-d603-419b-aca6-79389edfde36
Commercial Distribution StatusIn Commercial Distribution
Brand NameNS10411 Correct Site Marker; Sharpie Style; w/ Ruler and Labels
Version Model NumberNS10411
Catalog NumberNS10411
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
GS100787551008715 [Primary]
GS120787551008719 [Package]
Contains: 00787551008715
Package: CASE [400 Units]
In Commercial Distribution

FDA Product Code

FZZMARKER, SKIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-10-17
Device Publish Date2022-12-08

Devices Manufactured by XODUS MEDICAL, INC.

20787551040399 - 40664 Pink Pad Air-Assist EXT + Trendelenburg2024-04-22 40664 Pink Pad Air-Assist EXT + Trendelenburg
20787551040474 - 40665 Pink Pad Air-Assist Trendelenburg +2024-04-22 40665 Pink Pad Air-Assist Trendelenburg +
20787551040566 - RTK10547 Room Turn Over Kit2024-04-22 RTK10547 Room Turn Over Kit
20787551040573 - 40666 Pink Pad Air-Assist Trendelenburg +2024-04-22 40666 Pink Pad Air-Assist Trendelenburg +
20787551040580 - 40667 Pink Pad Air-Assist Trendelenburg +2024-04-22 40667 Pink Pad Air-Assist Trendelenburg +
20787551040597 - 40668 Pink Pad Air-Assist EXT + Trendelenburg2024-04-22 40668 Pink Pad Air-Assist EXT + Trendelenburg
20787551040603 - 40669 Pink Pad Air-Assist EXT + Trendelenburg2024-04-22 40669 Pink Pad Air-Assist EXT + Trendelenburg
20787551040610 - LPK10007 Lateral Positioning Kit2024-04-22 LPK10007 Lateral Positioning Kit

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