Sample: Opti-Tatt™ Dots

Basic Information

• Brand Name: Sample: Opti-Tatt™ Dots
• Primary DI: 00714646001023
• Version / Model: UTRT-24100
• Catalog Number: UTRT-24100
• Company Name: Bionix, LLC
• Labeler DUNS: 117844489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2023-06-12
• Public Version: 2
• Public Version Date: 2023-07-19
• Public Version Status: Update
• Public Device Record Key: 4d321928-2ee6-4587-a86b-39ae6f4880f9

Device Description

Sample: Opti-Tatt, Dot, Sheet of 3

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FZZ	MARKER, SKIN	General, Plastic Surgery	878.4660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61577	Skin marking sticker	A hypoallergenic adhesive device (sticker) intended to be affixed to a patient’s skin (e.g., forehead) as a point of reference (marker), typically for use with external diagnostic imaging techniques. This is a single-use device.	No	Active
62057	Skin marking transfer paper	A non-sterile, noninvasive device intended to transfer a grid of ink dots onto the skin surface to assist a clinical procedure, such as accurate subcutaneous injection spacing. It is a non-latex transfer paper designed to be applied to the skin and then peeled away to leave the ink dots, which are subsequently removed from the skin (e.g., with alcohol) after the procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00714646001122	GS1
Primary	00714646001023	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: To maximize shelf-life, keep Opti-Tatt in the freezer between use