NS10738 NS10736 Individually packed kits NS10738

GUDID 20787551039102

NS10738 NS10736 Individually packed kits

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 Skin marking pen, single-use Skin marking pen, single-use Skin marking pen, single-use

• Primary Device ID: 20787551039102
• NIH Device Record Key: e7665c66-d0f4-46a0-a10f-55e51b38ba2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NS10738 NS10736 Individually packed kits
• Version Model Number: NS10738
• Catalog Number: NS10738
• Company DUNS: 868042664
• Company Name: XODUS MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(724)337-5500
• Email: plloyd@xodusmedical.com
• Phone: +1(724)337-5500
• Email: plloyd@xodusmedical.com
• Phone: +1(724)337-5500
• Email: plloyd@xodusmedical.com
• Phone: +1(724)337-5500
• Email: plloyd@xodusmedical.com
• Phone: +1(724)337-5500
• Email: plloyd@xodusmedical.com
• Phone: +1(724)337-5500
• Email: plloyd@xodusmedical.com
• Phone: +1(724)337-5500
• Email: plloyd@xodusmedical.com
• Phone: +1(724)337-5500
• Email: plloyd@xodusmedical.com
• Phone: +1(724)337-5500
• Email: plloyd@xodusmedical.com
• Phone: +1(724)337-5500
• Email: plloyd@xodusmedical.com
• Phone: +1(724)337-5500
• Email: plloyd@xodusmedical.com
• Phone: +1(724)337-5500
• Email: plloyd@xodusmedical.com
• Phone: +1(724)337-5500
• Email: plloyd@xodusmedical.com
• Phone: +1(724)337-5500
• Email: plloyd@xodusmedical.com
• Phone: +1(724)337-5500
• Email: plloyd@xodusmedical.com
• Phone: +1(724)337-5500
• Email: plloyd@xodusmedical.com
• Phone: +1(724)337-5500
• Email: plloyd@xodusmedical.com
• Phone: +1(724)337-5500
• Email: plloyd@xodusmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00787551039108 [Primary]
GS1	20787551039102 [Package]; Contains: 00787551039108; Package: CASE [400 Units]; In Commercial Distribution

FDA Product Code

• FZZ: MARKER, SKIN

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-10-24
• Device Publish Date: 2022-12-08

Devices Manufactured by XODUS MEDICAL, INC.

• 20787551040399 - 40664 Pink Pad Air-Assist EXT + Trendelenburg: 2024-04-22 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 Kit: 2024-04-22 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 + Trendelenburg: 2024-04-22 40668 Pink Pad Air-Assist EXT + Trendelenburg
• 20787551040603 - 40669 Pink Pad Air-Assist EXT + Trendelenburg: 2024-04-22 40669 Pink Pad Air-Assist EXT + Trendelenburg
• 20787551040610 - LPK10007 Lateral Positioning Kit: 2024-04-22 LPK10007 Lateral Positioning Kit