EXTERNAL OCULID PINK® - 1,0 g

Basic Information

• Brand Name: EXTERNAL OCULID PINK® - 1,0 g
• Primary DI: 13700773727701
• Version / Model: S3.60101
• Company Name: FCI S A S FCI 20 22
• Labeler DUNS: 763408366
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-08
• Public Version: 1
• Public Version Date: 2022-03-16
• Public Version Status: New
• Public Device Record Key: 77c2ec57-1453-4451-a703-98976b5891c6

Device Description

EXTERNAL OCULID PINK® - 1,0 g

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MML	Weights, Eyelid, External	Ophthalmic	886.5700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18142	Eyelid weight, external	An ophthalmic device that is applied to the outside of the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle (musculus orbicularis oculi) function. This device can be used for: 1) the treatment of temporary facial paralysis caused by Bell's palsy, trauma, or a stroke; or 2) to determine the appropriate size of implantable eyelid weights prior to surgery. This device uses gravity to gently close the upper eyelid when blinking or when the eyelid muscle is relaxed, and is made of a heavy material (e.g., tantalum). It is worn just above the eyelashes, adhered to the skin with double-sided adhesive tape, and is coloured in a variety of skin shades (pink, tan, brown, dark brown).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	13700773727701	GS1