Eyelid weight, implantable

Primary DI
03760087120721
Brand
Eyelid weight, implantable
Company
FCI S A S FCI 20 22
Model
PTOSE-UP 3 mm WIDTH J.M. RUBAN, M.D.
Catalog number
S3.3001u
Device description
"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)]. "
Published
2020-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HJZCrutch, Ptosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJZCrutch, PtosisOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760087120721PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760087120721037600871207213760087120721

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid weight, implantableAn 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)].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length150Millimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
800-932-4202orders@fci-ophthalmics.com

Regulatory Flags#

DUNS number
763408366
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
13700773729651STOPLOSS® JONES TUBE 3,5 X 9 MM S1.73092026-04-20
13700773729668STOPLOSS® JONES TUBE 3,5 X 10 MM S1.73102026-04-20
13700773729675STOPLOSS® JONES TUBE 3,5 X 11 MM S1.73112026-04-20
13700773729682STOPLOSS® JONES TUBE 3,5 X 12 MM S1.73122026-04-20
13700773729699STOPLOSS® JONES TUBE 3,5 X 13 MM S1.73132026-04-20
13700773730817STOPLOSS® JONES TUBE INTRODUCER SET S1.75002026-04-20
13700773731920STOPLOSS® JONES TUBE 3,5 X 14 MM S1.73142026-04-20
13700773731937STOPLOSS® JONES TUBE 3,5 X 15 MM S1.73152026-04-20
13700773731968STOPLOSS® JONES TUBE 3,5 X 16 MM S1.73162026-04-20
13700773731975STOPLOSS® JONES TUBE 3,5 X 17 MM S1.73172026-04-20
13700773731982STOPLOSS® JONES TUBE 3,5 X 18 MM S1.73182026-04-20
13700773731999STOPLOSS® JONES TUBE 3,5 X 19 MM S1.73192026-04-20
13700773732002STOPLOSS® JONES TUBE 3,5 X 20 MM S1.73202026-04-20
13700773732019STOPLOSS® JONES TUBE 3,5 X 21 MM S1.73212026-04-20
13700773732026STOPLOSS® JONES TUBE 3,5 X 22 MM S1.73222026-04-20
13700773732033STOPLOSS® JONES TUBE 4 X 9 MM S1.74092026-04-20
13700773732040STOPLOSS® JONES TUBE 4 X 10 MM S1.74102026-04-20
13700773732057STOPLOSS® JONES TUBE 4 X 11 MM S1.74112026-04-20
13700773732064STOPLOSS® JONES TUBE 4 X 12 MM S1.74122026-04-20
13700773732071STOPLOSS® JONES TUBE 4 X 13 MM S1.74132026-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852578008298Matrix Seiff Ptosis SlingMATRIX SURGICAL HOLDINGS, LLCHJZ2025-06-05
03760087120714Eyelid weight, implantableFCI S A S FCI 20 22HJZ2020-02-26
33760087120715Eyelid weight, implantableFCI S A S FCI 20 22HJZ2020-02-26
03760087120806Eyelid weight, implantableFCI S A S FCI 20 22HJZ2020-02-25