Sample: Opti-Tatt™ Dots UTRT-24100

GUDID 00714646001122

Sample: Opti-Tatt, Dot, Sheet of 3

Bionix, LLC

Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker Skin marking sticker

• Primary Device ID: 00714646001122
• NIH Device Record Key: 4d321928-2ee6-4587-a86b-39ae6f4880f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sample: Opti-Tatt™ Dots
• Version Model Number: UTRT-24100
• Catalog Number: UTRT-24100
• Company DUNS: 117844489
• Company Name: Bionix, LLC
• Device Count: 3
• 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
• 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	00714646001023 [Primary]
GS1	00714646001122 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-20
• Device Publish Date: 2023-06-12

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