SANDEL 1019

GUDID 35414566830067

SANDEL SKIN MARKER

Ansell Sandel Medical Solutions LLC

Skin marking pen, single-use

• Primary Device ID: 35414566830067
• NIH Device Record Key: 68c9232e-4d37-4aae-8357-dd1324aea5c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SANDEL
• Version Model Number: 1019
• Catalog Number: 1019
• Company DUNS: 107961166
• Company Name: Ansell Sandel Medical Solutions LLC
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 775-746-6600
• Email: jacob.ramirez@ansell.com
• Phone: 775-746-6600
• Email: jacob.ramirez@ansell.com
• Phone: 775-746-6600
• Email: jacob.ramirez@ansell.com
• Phone: 775-746-6600
• Email: jacob.ramirez@ansell.com
• Phone: 775-746-6600
• Email: jacob.ramirez@ansell.com
• Phone: 775-746-6600
• Email: jacob.ramirez@ansell.com
• Phone: 775-746-6600
• Email: jacob.ramirez@ansell.com
• Phone: 775-746-6600
• Email: jacob.ramirez@ansell.com
• Phone: 775-746-6600
• Email: jacob.ramirez@ansell.com
• Phone: 775-746-6600
• Email: jacob.ramirez@ansell.com
• Phone: 775-746-6600
• Email: jacob.ramirez@ansell.com
• Phone: 775-746-6600
• Email: jacob.ramirez@ansell.com
• Phone: 775-746-6600
• Email: jacob.ramirez@ansell.com
• Phone: 775-746-6600
• Email: jacob.ramirez@ansell.com
• Phone: 775-746-6600
• Email: jacob.ramirez@ansell.com
• Phone: 775-746-6600
• Email: jacob.ramirez@ansell.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00071483005080 [Unit of Use]
GS1	25414566830060 [Primary]
GS1	35414566830067 [Package]; Contains: 25414566830060; Package: Case [100 Units]; In Commercial Distribution

FDA Product Code

• FZZ: Marker, Skin

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-04
• Device Publish Date: 2022-03-25

On-Brand Devices [SANDEL]

• 00071483005073: SANDEL PETITE SKIN MARKER, BULK (NS)
• 35414566830128: SANDEL 4-IN-1 MARKER W/RULER
• 35414566830111: SANDEL SKIN MARKER W/RULER
• 35414566830074: SANDEL 4-IN-1 MARKER
• 35414566830067: SANDEL SKIN MARKER
• 00071483005196: NON-WEIGHTED SAFETY SCALPEL, #11 BLADE, BULK (NS)
• 35414566810243: SANDEL SAFETY SCALPEL HANDLE, CAB (NS)
• 35414566810212: STRETCH-A-TRAY, W/ADHESIVE
• 35414566810205: STRETCH-A-TRAY, W/ADHESIVE, BULK (NS)
• 35414566810199: Z-FRICTION DRAPE, 10"X16" BULK (NS)
• 35414566810182: Z-TRAY, W/ADHESIVE, BULK (NS)
• 35414566810151: Z-FRICTION DRAPE, 10"X16"
• 35414566810014: SANDEL SAFETY SCALPEL HANDLE, CAB, 2200
• 25414566810338: NON-WEIGHTED SAFETY SCALPEL, #15 BLADE, BULK (NS)
• 35414566810311: NON-WEIGHTED SAFETY SCALPEL, #10 BLADE, BULK (NS)
• 35414566810304: WEIGHTED SAFETY SCALPEL, #20 BLADE, BULK (NS)
• 35414566810298: WEIGHTED SAFETY SCALPEL, #15 BLADE, BULK (NS)
• 35414566810281: WEIGHTED SAFETY SCALPEL, #11 BLADE, BULK (NS)
• 35414566810274: WEIGHTED SAFETY SCALPEL, #10 BLADE, BULK (NS)
• 35414566810267: SANDEL SAFETY SCALPEL HANDLE, #4 CAB (NS)
• 35414566810250: SANDEL SAFETY SCALPEL HANDLE-LONG, CAB (NS)
• 35414566810144: Z-TRAY, W/ADHESIVE
• 35414566810137: NON-WEIGHTED SAFETY SCALPEL, #15 BLADE
• 35414566810120: NON-WEIGHTED SAFETY SCALPEL, #11 BLADE
• 35414566810113: NON-WEIGHTED SAFETY SCALPEL, #10 BLADE
• 35414566810106: WEIGHTED SAFETY SCALPEL, #20 BLADE
• 35414566810083: WEIGHTED SAFETY SCALPEL, #15 BLADE
• 35414566810069: WEIGHTED SAFETY SCALPEL, #11 BLADE
• 35414566810045: WEIGHTED SAFETY SCALPEL, #10 BLADE
• 35414566810038: SANDEL SAFETY SCALPEL HANDLE, #4 CAB