FDA.reportPublic FDA data

LLL Proportional 1.8 grams

Primary DI
00871321002451
Brand
LLL Proportional 1.8 grams
Company
Labtician Ophthalmics, Inc
Model
SGP18
Published
2015-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MMLWeights, Eyelid, External

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMLWeights, Eyelid, ExternalOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00871321002451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00871321002451008713210024518713210024510871321002451

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)].

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
905-829-0055philcuscuna@labtician.com

Regulatory Flags#

DUNS number
248911026
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00871321000013Oval SpongeS 1981-42026-10-01
00871321000020Oval SpongeS 1981-52026-10-01
00871321000044Oval SpongeS 1981-7.52026-10-01
00871321000051Round Sponge 1.5mmS 1982-1.52026-10-01
00871321000068Round Sponge 2mmS 1982-22026-10-01
00871321000075Round Sponge 2.5mmS 1982-2.52026-10-01
00871321000082Round Sponge 3mmS 1982-32026-10-01
008713210000993.0mm Round SpongeS 1982-3-M2026-10-01
00871321000105Round Sponge 4mmS 1982-42026-10-01
00871321000112Round Sponge 5mmS 1982-52026-10-01
008713210001295.0mm Round SpongeS 1982-5-M2026-10-01
00871321000136Round Tunnel Sponge 5mmS 1982-5T2026-10-01
00871321000143Round Sponge 7mmS 1982-72026-10-01
00871321000150Round Sponge 7.5mm x 50mmS 1982-7.52026-10-01
00871321000167Grooved SpongeS 1983-2.32026-10-01
00871321000174Grooved Part Thickness SpongeS 1983-2.52026-10-01
00871321000181Grooved Part Thickness SpongeS 1983-2.82026-10-01
00871321000198Grooved SpongeS 1983-32026-10-01
00871321000204Grooved SpongeS 1983-3.22026-10-01
00871321000211Grooved SpongeS 1983-3.52026-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EHKM80001111Test Weight Set Upper Eyelid ImplantHeinz Kurz GmbHMML2026-04-07
00813142021303BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021310BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021327BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021334BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021341BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021358BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021365BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021372BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021389BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021396BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021402BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021419BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021426BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021433BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021440BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021457BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021464BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021471BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021488BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021495BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021501BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021518BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021525BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021532BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021549BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021556BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021563BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021570BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021587BlinkezeMEDDEV CORPORATIONMML2023-11-28