Consulting Wallah › Device Explorer › Other devices › Scleral buckling device, non-bioabsorbable
Device Explorer · FDA GUDID · GMDN 42545

Scleral buckling device, non-bioabsorbable

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

US‑registered devices245in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription44%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Labtician Ophthalmics, Inc9137%
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.4820%
Mira, Inc.4518%
Fci S A S Fci 20 224318%
Microvision, Inc.187%

Top labelers

CompanyDevicesShare
Labtician Ophthalmics, Inc9137%
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.4820%
Mira, Inc.4518%
Fci S A S Fci 20 224318%
Microvision, Inc.187%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Scleral buckling device, non-bioabsorbableHALF-SPONGE 2.75 X 7.5 TYPE 511Combo PackBuckling SleeveSilicone Tire Wide GrooveSilicone StripWong Meridional ImplantSilicone Lace™ 2.5mmSilicone Lace™ 2mmOval SleeveSilicone SleeveWedgeMeridional ImplantSilicone TireSilicone Tire 10mmSilicone Tire 7mm WG

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
HQXImplant, Orbital, Extra-Ocular155
HQJImplant, Absorbable, (Scleral Buckling Methods)93

GMDN & GCC registration

  • GMDN code 42545 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 44% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 50Width (Millimeter) · 44Height (Millimeter) · 34Outer Diameter (Millimeter) · 23Lumen/Inner Diameter (Millimeter) · 8

Use these as the dimensions to specify in a tender line.

How many scleral buckling device, non-bioabsorbable products are registered in the US?

245 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Scleral buckling device, non-bioabsorbable", from 5 companies. The largest labeler is Labtician Ophthalmics, Inc with 37% of records.

Which FDA product codes apply?

HQX (Implant, Orbital, Extra-Ocular), HQJ (Implant, Absorbable, (Scleral Buckling Methods))

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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