SteriTatt

Basic Information

• Brand Name: SteriTatt
• Primary DI: 00843696195014
• Version / Model: 90002
• Company Name: Flow X Ray Corporation
• Labeler DUNS: 010016319
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2020-08-07
• Public Version: 2
• Public Version Date: 2023-06-28
• Public Version Status: Update
• Public Device Record Key: 78d3db36-0d06-4852-b484-ac5c5c271864

Device Description

25 Single Service SteriTatt Markers and 25 sterile needles

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: Yes
• 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
61783	Tattoo ink, dermal	A sterile, synthetic, implantable dye solution intended to be injected between the layers of the skin, using a tattoo needle and hand-held ink injector, for aesthetic pigmentation of the skin and visible mucous membranes. It is typically pH balanced for dermal applications and does not contain animal-derived materials. It may be implanted for a variety of reasons (e.g., for cosmetic decoration, to replace colour in the skin for patients affected by pigment deficiencies, for radiotherapy marking).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00843696195014	GS1
Unit of Use	30843696195015	GS1

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 18 – 25 Degrees Celsius