Consulting Wallah › Device Explorer › Other devices › Medical equipment drape, single-use, non-sterile
Device Explorer · FDA GUDID · GMDN 63712

Medical equipment drape, single-use, non-sterile

A non-sterile flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tube

US‑registered devices67in commercial distribution
Companies8labelers on GUDID
Single‑use85%of device records
Sterile0%labelled sterile
Prescription15%Rx‑only share
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Share of device records

Darby Dental Supply, Llc1928%
Henry Schein, Inc.1725%
Palodex Group Oy913%
Euronda Spa812%
Carestream Dental Llc69%
Acuderm, Inc.46%
Burkhart Dental Supply Co., The34%
Protek Medical Products, Inc.11%

Top labelers

CompanyDevicesShare
Darby Dental Supply, Llc1928%
Henry Schein, Inc.1725%
Palodex Group Oy913%
Euronda Spa812%
Carestream Dental Llc69%
Acuderm, Inc.46%
Burkhart Dental Supply Co., The34%
Protek Medical Products, Inc.11%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PROTECTIVE BAG SIZE 3 100 PCSPROTECTIVE BAG SIZE 2 100 PCSPROTECTIVE BAG SIZE 1 100 PCSEAR ROD COVER DISPOSABLE CC3DISPOSABLE COVER ROLLLIP SUPPORT DISPOSABLE COVERBITE BLOCK DISPOSABLE COVER ROLLDISPOSABLE PLASTIC BAG BIG FMX NEWDISPOSABLE PLASTIC BAGS SIZE 0 DIGORA OPTIME 100MonoartDarby Dental Supply, LLCPhosphor Plate Barrier Envelopes (Size 1)Phosphor Plate Barrier Envelopes (Size 2)Phosphor Plate Barrier Envelopes (Size 0)ACU-GUARDSINGLE USE SLEEVES - EAR RODS

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

FDA product codes

CodeNameDevices
NRUCHAIR, DENTAL, WITHOUT OPERATIVE UNIT36
PEMDental Barriers And Sleeves9
NRUChair, Dental, Without Operative Unit8
PUIDrape, surgical, exempt6
GEXPowered Laser Surgical Instrument4
IWXBarrier, Control Panel, X-Ray, Movable3

GMDN & GCC registration

  • GMDN code 63712 · non‑implantable
  • Single‑use 85% · sterile 0% · Rx‑only 15% · OTC 9%
  • 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) · 10Weight (Gram) · 1

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

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

67 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Medical equipment drape, single-use, non-sterile", from 8 companies. The largest labeler is Darby Dental Supply, Llc with 28% of records.

Which FDA product codes apply?

NRU (CHAIR, DENTAL, WITHOUT OPERATIVE UNIT), PEM (Dental Barriers And Sleeves), NRU (Chair, Dental, Without Operative Unit), 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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