Consulting Wallah › Device Explorer › Ophthalmic › Ophthalmic surgical drape
Device Explorer · FDA GUDID · GMDN 46697

Ophthalmic surgical drape

A protective covering made of natural or synthetic materials, or both, designed to promote a clean and dry sterile field about the eye during ophthalmic surgery or refractive and general ophthalmic office procedures. The device may be used to cover the eyebrow

US‑registered devices156in commercial distribution
Companies9labelers on GUDID
Single‑use100%of device records
Sterile49%labelled sterile
Prescription64%Rx‑only share
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Share of device records

Atlanta Healthcare Services, Inc.7850%
Cardinal Health 200, Llc3422%
Microspecialities, Inc.149%
Medline Industries, Inc.106%
Eagle Labs85%
Nuline Limited64%
Resource Optimization & Innovation, L.L.C.32%
American Medicals21%

Top labelers

CompanyDevicesShare
Atlanta Healthcare Services, Inc.7850%
Cardinal Health 200, Llc3422%
Microspecialities, Inc.149%
Medline Industries, Inc.106%
Eagle Labs85%
Nuline Limited64%
Resource Optimization & Innovation, L.L.C.32%
American Medicals21%
Microtek Medical Llc11%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Full body incise drape wetlaid 140 x 244cmFull body aperture drape wetlaid 140 x 244cmSmall half body incise drape wetlaid 100x127cmSmall half body aperture drape wetlaid 100x127cmMedium half body apeture drape wetlaid 127 x 140Medium half body incise drape wetlaid 127x140cmN/AMICROTEKRegard™American MedicalsCONVERTORSMedlineAtlanta Healthcare Services OcuDrape®PRO-PAKS®️

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

FDA product codes

CodeNameDevices
HMTDrape, patient, ophthalmic140
HMTDrape, Patient, Ophthalmic35
KKXDrape, surgical19
PUIDrape, surgical, exempt3
MDMInstrument, Manual, Surgical, General Use2
FRLFiber, Medical, Absorbent1

GMDN & GCC registration

  • GMDN code 46697 · non‑implantable
  • Single‑use 100% · sterile 49% · Rx‑only 64% · OTC 30%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Inch) · 99Length (Inch) · 99Length (Centimeter) · 14Width (Centimeter) · 14Area/Surface Area (Square inch) · 6

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

How many ophthalmic surgical drape products are registered in the US?

156 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ophthalmic surgical drape", from 9 companies. The largest labeler is Atlanta Healthcare Services, Inc. with 50% of records.

Which FDA product codes apply?

HMT (Drape, patient, ophthalmic), HMT (Drape, Patient, Ophthalmic), KKX (Drape, surgical), PUI (Drape, surgical, exempt)

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.

How do I get quotes?

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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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