Consulting Wallah › Device Explorer › Ophthalmic › Vitrectomy contact lens, reusable
Device Explorer · FDA GUDID · GMDN 58037

Vitrectomy contact lens, reusable

A non-sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless le

US‑registered devices87in commercial distribution
Companies3labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription49%Rx‑only share
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Share of device records

Ocular Instruments, Inc.5664%
Volk Optical Inc.2933%
Rxsight, Inc.22%

Top labelers

CompanyDevicesShare
Ocular Instruments, Inc.5664%
Volk Optical Inc.2933%
Rxsight, Inc.22%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

RxSight Contact LensHRX SSV ACS (VHRXVITSSVACS)HRX ACS (VHRXVITACS)HR Direct HM NSR Vit (VHRDHMNSRACS)HR Direct HighMag Vit (VHRDHMACS)HR Direct Bi-Concave (VHRDBCACS)HR Direct Prism Vit (VHRD20PACS)HR Direct 1X NSR Vit (VHRD1XNSRACS)HR Direct 1X Vit (VHRD1XACS)AFX SSV ACS (VAFXSSVACS)Mid Field SSV ACS (VMFSSVACS)High Mag SSV ACS (VFHMSSVACS)45 Prism SSV ACS (V45PRISMSSVACS)30 Prism SSV ACS (V30PRISMSSVACS)15 Prism SSV ACS (VPRISMSSVACS)Flat SSV ACS (VFLATSSVACS)

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

FDA product codes

CodeNameDevices
HJKLens, Contact, Polymethylmethacrylate, Diagnostic78
HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic12
MLPKeratoprosthesis, Temporary Implant, Surgical Use7
HJLLens, Condensing, Diagnostic1

GMDN & GCC registration

  • GMDN code 58037 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 49% · 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

No structured size data on the register.

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

How many vitrectomy contact lens, reusable products are registered in the US?

87 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Vitrectomy contact lens, reusable", from 3 companies. The largest labeler is Ocular Instruments, Inc. with 64% of records.

Which FDA product codes apply?

HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic), HRM (Microscope, Operating & Accessories, Ac-Powered, Ophthalmic), MLP (Keratoprosthesis, Temporary Implant, Surgical Use), HJL (Lens, Condensing, Diagnostic)

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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