FDA.reportPublic FDA data

Tantalum Set (0.6g to 1.8g) and 60 strips 7 weights

Primary DI
00871321002871
Brand
Tantalum Set (0.6g to 1.8g) and 60 strips 7 weights
Company
Labtician Ophthalmics, Inc
Model
NST100
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
00871321002871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00871321002871008713210028718713210028710871321002871

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
10871321002526LabVit KitLVK1000, LVK1100N/A2018-02-26
00871321000297Labtician Lid Load Adhesive StripsNST 400NST 4002018-08-07
10871321001369Grooved SpongeS 1983-3.22015-10-05
10871321001628Silicone Tire 10mmS 29772015-10-09
10871321001635Meridional Implant - FlatS 29782015-10-09
10871321001642Silicone Tire 7mmS 29862015-10-09
10871321001659Circling BandS 29872015-10-09
108713210016662.5mm Circling BandS 2987-M2018-02-22
10871321001673Meridional ImplantS 29882015-10-09
10871321001680BoatS 29892015-10-09
10871321001697Silicone Tire 9mmS 29912015-10-09
10871321001703Silicone StripS 29922015-10-09
108713210017102.5mm Grooved StripS 2992-M2018-02-22
10871321001727PadS 29932015-10-09
10871321001734Silicone Tire 6.0mmS 29942015-10-09
10871321001741Silicone Tire 8.5mmS 29952015-10-09
10871321001758Silicone Tire 10mmS 29962015-10-09
10871321001765Silicone Tire 10mm LGS 2996 L2015-10-09
10871321001772Silicone Tire 12.5mmS 29972015-10-09
10871321001789Silicone StripS 29982015-10-09

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