Artisan/Artiflex

Basic Information

• Brand Name: Artisan/Artiflex
• Primary DI: 08717819049176
• Version / Model: OD125A
• Catalog Number: OD125A
• Company Name: Ophtec B.V.
• Labeler DUNS: 405048120
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-24
• Public Version: 4
• Public Version Date: 2023-06-09
• Public Version Status: Update
• Public Device Record Key: d771ab9c-6080-4042-a86e-e611b66d6742

Device Description

Enclavation Needles

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: No
• 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
MRJ	Ring, Endocapsular	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
44359	Ophthalmic surgical probe, single-use	A slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08717819049176	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K030471	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Shelf-packs should be stored in a dry, climate-controlled environment