tarSys

Basic Information

• Brand Name: tarSys
• Primary DI: 00841668112212
• Version / Model: TS-81040
• Catalog Number: TS-81040
• Company Name: KATENA PRODUCTS, INC.
• Labeler DUNS: 085668598
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 3
• Public Version Date: 2020-11-06
• Public Version Status: Update
• Public Device Record Key: 63797655-e48e-4e34-8f7a-3f85b166ac9f

Device Description

tarSys-Bio-engineered eyelid spacer graft 8 layer 1 x 4 cm

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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NXM	Prosthesis, Eyelid Spacer/Graft, Biologic	Ophthalmic	886.3130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45357	Eyelid xenograft	A device derived from animal tissues (porcine) that is prepared into sheets of various sizes and thicknesses appropriate for the grafting, reconstruction, and repair of the soft tissue of the eyelid. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841668112212	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	1	Centimeter
Length	4	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Ambient Temperature