Toric Alignment Marker, 3, 6, 9 O'Clock

Basic Information

• Brand Name: Toric Alignment Marker, 3, 6, 9 O'Clock
• Primary DI: 05060480408265
• Version / Model: 91-6001
• Company Name: BLINK MEDICAL LIMITED
• Labeler DUNS: 738288096
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-30
• Public Version: 2
• Public Version Date: 2023-08-03
• Public Version Status: Update
• Public Device Record Key: e614e2c6-08db-4140-b7b6-f35285058a10

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: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HMR	Marker, Ocular	Ophthalmic	886.4570	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42367	Scleral marker, reusable	A manual instrument intended to be used to indent or imprint the surface of the sclera during an ophthalmic surgical or perioperative procedure. It is typically a hand-held instrument or a thimble-like device (placed on the end of a finger) and is made of metal (e.g., high-grade stainless steel) or synthetic polymer material. Various types are available, including the Gass scleral marker that creates a minuscule indentation, the Awh scleral marker that creates parallel scored lines, and the Awh horseshoe design. The device is typically used for retinal detachment surgery. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060480408265	GS1
Package	05060480402768	GS1		10	In Commercial Distribution