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Device Explorer · FDA GUDID · GMDN 61049

Instrument/equipment drape, single-use, non-sterile

A non-sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various instruments/equipment (e.g., dental chairs, treatment tables), to provide a barrier against cross-contamination in t

US‑registered devices222in commercial distribution
Companies20labelers on GUDID
Single‑use100%of device records
Sterile1%labelled sterile
Prescription43%Rx‑only share
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Share of device records

Premium Plus International Limited6529%
Metrex Research, Llc4118%
Medline Industries, Inc.2612%
Sirona Dental, Inc.178%
Benco Dental Supply Co.136%
Henry Schein, Inc.94%
Dental Health Products Inc84%
Burkhart Dental Supply Co., The73%

Top labelers

CompanyDevicesShare
Premium Plus International Limited6529%
Metrex Research, Llc4118%
Medline Industries, Inc.2612%
Sirona Dental, Inc.178%
Benco Dental Supply Co.136%
Henry Schein, Inc.94%
Dental Health Products Inc84%
Burkhart Dental Supply Co., The73%
National Distribution & Contracting, Inc.73%
Spectrum, Inc.52%
Summit Medical, Inc.42%
Maxill, Inc.42%

Company = labeler of record on GUDID. 20 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DEXIS Platinum™ intraoral sensor sheathsGendex GXS-700™ intraoral sensor sheathsGendex GXS-700™ intraoral sensorPEARSONSOLEILPremium PlusSpectrum, Inc.Burkhart X-Ray Sleeves 15X26 (250)Burkhart Chair Covers Plastic 27X24 (225)Burkhart Syringe Sleeve W/Opening (500)Burkhart Cover Film Blue 4X6 (1200)Burkhart Cover Film Clear 4X6 (1200)Burkhart Light Sleeves T-Style 4X5.75 (500)"Burkhart Tray Sleeve Size B 10.5""X14"" (500)"Health-Tec Barrier FilmHealth-Tec Chair Sleeves

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

FDA product codes

CodeNameDevices
PEMDental Barriers And Sleeves81
MMPCover, barrier, protective54
KKXDrape, surgical29
MMPCover, Barrier, Protective14
EFBHandpiece, Air-Powered, Dental13
EFBHANDPIECE, AIR-POWERED, DENTAL13

GMDN & GCC registration

  • GMDN code 61049 · non‑implantable
  • Single‑use 100% · sterile 1% · Rx‑only 43% · OTC 44%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 2Width (Inch) · 2

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

How many instrument/equipment drape, single-use, non-sterile products are registered in the US?

222 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Instrument/equipment drape, single-use, non-sterile", from 20 companies. The largest labeler is Premium Plus International Limited with 29% of records.

Which FDA product codes apply?

PEM (Dental Barriers And Sleeves), MMP (Cover, barrier, protective), KKX (Drape, surgical), MMP (Cover, Barrier, Protective)

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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