Sample: Opti-Tatt Dots SP-24100

GUDID 10714646001020

Sample: Opti-Tatt, Dot, Sheet of 3

Bionix, LLC

Skin marking transfer paper

• Primary Device ID: 10714646001020
• NIH Device Record Key: 4d321928-2ee6-4587-a86b-39ae6f4880f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sample: Opti-Tatt Dots
• Version Model Number: SP-24100
• Catalog Number: SP-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

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	10714646001020 [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: 3
• Public Version Date: 2024-09-26
• Device Publish Date: 2023-06-12

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