Eyelid weight, implantable S3.3021u

GUDID 03760087120806

An ophthalmic device that is implanted subcutaneously within the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle (musculus orbicularis oculi) function. This device is used for the treatment of lagophthalmos, a condition that frequently results from facial paralysis caused by Bell's palsy, trauma, a stroke, or as an indirect consequence of the surgical removal of certain types of tumour in close proximity to the facial nerve. 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., gold (Au), platinum (Pt)].

FCI S A S FCI 20 22

Eyelid weight, implantable

• Primary Device ID: 03760087120806
• NIH Device Record Key: 001ec056-2e5e-4f1e-b0c7-69f0a7efb8f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eyelid weight, implantable
• Version Model Number: PTOSE-UP 2 mm WIDTH J.M. RUBAN M.D.
• Catalog Number: S3.3021u
• Company DUNS: 763408366
• Company Name: FCI S A S FCI 20 22
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-932-4202
• Email: orders@fci-ophthalmics.com

Device Dimensions

• Length: 150 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760087120806 [Primary]

FDA Product Code

• HJZ: Crutch, Ptosis

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[03760087120806]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-04
• Device Publish Date: 2020-02-25

On-Brand Devices [Eyelid weight, implantable]

• 03760087120806: An ophthalmic device that is implanted subcutaneously within the upper eyelid to "lidload" the e
• 03760087120721: An ophthalmic device that is implanted subcutaneously within the upper eyelid to "lidload" the e
• 33760087120715: An ophthalmic device that is implanted subcutaneously within the upper eyelid to "lidload" the e