FDA.reportPublic FDA data

Scleral buckling device, non-bioabsorbable

Definition
A non-bioabsorbable device intended to be implanted for intrascleral and episcleral buckling for the surgical treatment of retinal detachment. It is typically a moulded solid silicone or silicone sponge device available in a variety of shapes and sizes that is used to compress the retina long-term (up to months) to support its reattachment following the operative treatment of severe retinal detachment. This device, also known as a scleral buckling component, will occupy the intraocular space to provide compression against the retina so that it can reattach. It is typically removed after a period of time depending upon the clinical findings.
GUDID devices
297
Last updated
2026-10-13 01:13:58

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00871321000013Oval SpongeLabtician Ophthalmics, IncS 1981-42026-10-01
00871321000020Oval SpongeLabtician Ophthalmics, IncS 1981-52026-10-01
00871321000044Oval SpongeLabtician Ophthalmics, IncS 1981-7.52026-10-01
00871321000051Round Sponge 1.5mmLabtician Ophthalmics, IncS 1982-1.52026-10-01
00871321000068Round Sponge 2mmLabtician Ophthalmics, IncS 1982-22026-10-01
00871321000075Round Sponge 2.5mmLabtician Ophthalmics, IncS 1982-2.52026-10-01
00871321000082Round Sponge 3mmLabtician Ophthalmics, IncS 1982-32026-10-01
008713210000993.0mm Round SpongeLabtician Ophthalmics, IncS 1982-3-M2026-10-01
00871321000105Round Sponge 4mmLabtician Ophthalmics, IncS 1982-42026-10-01
00871321000112Round Sponge 5mmLabtician Ophthalmics, IncS 1982-52026-10-01
008713210001295.0mm Round SpongeLabtician Ophthalmics, IncS 1982-5-M2026-10-01
00871321000136Round Tunnel Sponge 5mmLabtician Ophthalmics, IncS 1982-5T2026-10-01
00871321000143Round Sponge 7mmLabtician Ophthalmics, IncS 1982-72026-10-01
00871321000150Round Sponge 7.5mm x 50mmLabtician Ophthalmics, IncS 1982-7.52026-10-01
00871321000167Grooved SpongeLabtician Ophthalmics, IncS 1983-2.32026-10-01
00871321000174Grooved Part Thickness SpongeLabtician Ophthalmics, IncS 1983-2.52026-10-01
00871321000181Grooved Part Thickness SpongeLabtician Ophthalmics, IncS 1983-2.82026-10-01
00871321000198Grooved SpongeLabtician Ophthalmics, IncS 1983-32026-10-01
00871321000204Grooved SpongeLabtician Ophthalmics, IncS 1983-3.22026-10-01
00871321000211Grooved SpongeLabtician Ophthalmics, IncS 1983-3.52026-10-01
00871321000228Grooved SpongeLabtician Ophthalmics, IncS 1983-42026-10-01
00871321000242Grooved SpongeLabtician Ophthalmics, IncS 1983-7.52026-10-01
00871321000259Partial Thickness SpongeLabtician Ophthalmics, IncS 1984-2.52026-10-01
00871321000266Partial Thickness SpongeLabtician Ophthalmics, IncS 1984-32026-10-01
00871321000273Partial Thickness SpongeLabtician Ophthalmics, IncS 1984-3.32026-10-01
00871321000280Partial Thickness SpongeLabtician Ophthalmics, IncS 1984-52026-10-01
00871321000303Scholda Partial ThicknessLabtician Ophthalmics, IncS 1985-52026-10-01
00871321000310Scholda Partial ThicknessLabtician Ophthalmics, IncS 1985-72026-10-01
00871321000327Oblong SpongeLabtician Ophthalmics, IncS 1986-3.52026-10-01
00871321000334Oblong SpongeLabtician Ophthalmics, IncS 1986-42026-10-01
00871321000358Accessory SpongeLabtician Ophthalmics, IncS 1987-82026-10-01
00871321000402Circling BandLabtician Ophthalmics, IncS 29502026-10-01
00871321000419Silicone StripLabtician Ophthalmics, IncS 29652026-10-01
00871321000426Silicone StripLabtician Ophthalmics, IncS 29672026-10-01
00871321000433Silicone StripLabtician Ophthalmics, IncS 29682026-10-01
00871321000440Circling BandLabtician Ophthalmics, IncS 29692026-10-01
00871321000457Silicone StripLabtician Ophthalmics, IncS 29702026-10-01
00871321000464Silicone StripLabtician Ophthalmics, IncS 29712026-10-01
00871321000471Silicone ButtonLabtician Ophthalmics, IncS 29762026-10-01
00871321000488Silicone Tire 10mmLabtician Ophthalmics, IncS 29772026-10-01
00871321000495Meridional Implant - FlatLabtician Ophthalmics, IncS 29782026-10-01
00871321000501Silicone Tire 7mmLabtician Ophthalmics, IncS 29862026-10-01
00871321000518Circling BandLabtician Ophthalmics, IncS 29872026-10-01
008713210005252.5mm Circling BandLabtician Ophthalmics, IncS 2987-M2026-10-01
00871321000532Meridional ImplantLabtician Ophthalmics, IncS 29882026-10-01
00871321000549BoatLabtician Ophthalmics, IncS 29892026-10-01
00871321000556Silicone Tire 9mmLabtician Ophthalmics, IncS 29912026-10-01
00871321000563Silicone StripLabtician Ophthalmics, IncS 29922026-10-01
008713210005702.5mm Grooved StripLabtician Ophthalmics, IncS 2992-M2026-10-01
00871321000587PadLabtician Ophthalmics, IncS 29932026-10-01
00871321000594Silicone Tire 6.0mmLabtician Ophthalmics, IncS 29942026-10-01
00871321000600Silicone Tire 8.5mmLabtician Ophthalmics, IncS 29952026-10-01
00871321000617Silicone Tire 10mmLabtician Ophthalmics, IncS 29962026-10-01
00871321000624Silicone Tire 10mm LGLabtician Ophthalmics, IncS 2996 L2026-10-01
00871321000631Silicone Tire 12.5mmLabtician Ophthalmics, IncS 29972026-10-01
00871321000648Silicone StripLabtician Ophthalmics, IncS 29982026-10-01
00871321000655Silicone Tire 7.0mmLabtician Ophthalmics, IncS 29992026-10-01
00871321000662Silicone Tire 9mmLabtician Ophthalmics, IncS 30042026-10-01
00871321000679Silicone Tire 6mmLabtician Ophthalmics, IncS 30102026-10-01
00871321000686BoatLabtician Ophthalmics, IncS 30122026-10-01
00871321000709Silicone Tire 7mmLabtician Ophthalmics, IncS 30142026-10-01
00871321000716Silicone Tire 7mm WGLabtician Ophthalmics, IncS 3014 L2026-10-01
00871321000723Silicone Tire 10mmLabtician Ophthalmics, IncS 30162026-10-01
00871321000730Silicone TireLabtician Ophthalmics, IncS 30172026-10-01
00871321000747Silicone SleeveLabtician Ophthalmics, IncS 30182026-10-01
00871321000754Silicone SleeveLabtician Ophthalmics, IncS 30192026-10-01
00871321000761Meridional ImplantLabtician Ophthalmics, IncS 30202026-10-01
00871321000778WedgeLabtician Ophthalmics, IncS 30212026-10-01
00871321000785WedgeLabtician Ophthalmics, IncS 30222026-10-01
00871321000792Silicone SleeveLabtician Ophthalmics, IncS 30712026-10-01
00871321000808Oval SleeveLabtician Ophthalmics, IncS 30832026-10-01
00871321000815Oval SleeveLabtician Ophthalmics, IncS 30842026-10-01
00871321000822Silicone StripLabtician Ophthalmics, IncS 40502026-10-01
00871321000839Silicone StripLabtician Ophthalmics, IncS 40552026-10-01
00871321000846Silicone StripLabtician Ophthalmics, IncS 40652026-10-01
00871321000884Silicone Lace™ 2mmLabtician Ophthalmics, IncS 50202026-10-01
00871321000891Silicone Lace™ 2.5mmLabtician Ophthalmics, IncS 50252026-10-01
00871321000921Double Tantalum Clip 2.0mmLabtician Ophthalmics, IncS 5662026-10-01
00871321000938Double Tantalum Clip 2.5mmLabtician Ophthalmics, IncS 5672026-10-01
00871321000945Combo PackLabtician Ophthalmics, IncS 69182026-10-01