Opti-Tatt™ Dots UTRT-4100

GUDID 10714646000993

Opti-Tatt, Dot, Sheet of 24

Bionix, LLC

Skin marking transfer paper

• Primary Device ID: 10714646000993
• NIH Device Record Key: 8cff6c05-fead-47e6-b167-cdcfee0c54c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Opti-Tatt™ Dots
• Version Model Number: UTRT-4100
• Catalog Number: UTRT-4100
• Company DUNS: 117844489
• Company Name: Bionix, LLC
• Device Count: 24
• DM Exempt: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use

Device Identifiers

Device Issuing Agency	Device ID
GS1	00714646000996 [Primary]
GS1	10714646000993 [Unit of Use]

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: 4
• Public Version Date: 2024-09-26
• Device Publish Date: 2023-06-12

On-Brand Devices [Opti-Tatt™ Dots]

• 00714646001092: Opti-Tatt, Dot, Sheet of 24
• 10714646000993: Opti-Tatt, Dot, Sheet of 24