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Device Explorer · FDA GUDID · GMDN 59258

Vitrectomy system micro-cutting unit

A sterile, pneumatically-powered, hand-held cutting tool that incorporates a vitrectomy system handpiece, micro-tip and connecting tubing as a single unit, intended to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the

US‑registered devices90in commercial distribution
Companies7labelers on GUDID
Single‑use98%of device records
Sterile98%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Medical Instrument Development Laboratories, Inc.5662%
Alcon Laboratories, Inc.1314%
Synergetics Usa, Inc.910%
Microvision, Inc.44%
Bausch & Lomb Incorporated33%
Oertli-Instrumente Ag33%
Medical Technical Products, Inc.22%

Top labelers

CompanyDevicesShare
Medical Instrument Development Laboratories, Inc.5662%
Alcon Laboratories, Inc.1314%
Synergetics Usa, Inc.910%
Microvision, Inc.44%
Bausch & Lomb Incorporated33%
Oertli-Instrumente Ag33%
Medical Technical Products, Inc.22%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Vitrector, M3000, 20GAVitrector, M2000, 20GANABi-Blade®Bi-Blade™CONSTELLATION HYPERVIT ENGAUGEUNITYCONSTELLATION ULTRAVIT ENGAUGESynergeticsBausch + LombOertli®

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

FDA product codes

CodeNameDevices
HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered62
MLZVitrectomy, Instrument Cutter9
HQEInstrument, vitreous aspiration and cutting, ac-powered9
HQCUnit, Phacofragmentation8
HKPInstrument, Vitreous Aspiration And Cutting, Battery-Powered5
MLZVitrectomy, instrument cutter4

GMDN & GCC registration

  • GMDN code 59258 · non‑implantable
  • Single‑use 98% · sterile 98% · Rx‑only 100% · 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

Needle Gauge (Gauge) · 65Pressure (Pound per Square Inch) · 4Outer Diameter (Millimeter) · 4

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

How many vitrectomy system micro-cutting unit products are registered in the US?

90 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Vitrectomy system micro-cutting unit", from 7 companies. The largest labeler is Medical Instrument Development Laboratories, Inc. with 62% of records.

Which FDA product codes apply?

HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), MLZ (Vitrectomy, Instrument Cutter), HQE (Instrument, vitreous aspiration and cutting, ac-powered), HQC (Unit, Phacofragmentation)

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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