Consulting Wallah › Device Explorer › Endoscopy & surgical instruments › Instrument tray cover, single-use
Device Explorer · FDA GUDID · GMDN 64367

Instrument tray cover, single-use

A flexible, synthetic polymer cover designed to be placed on an instrument tray to provide a protective barrier for the transport and short-term storage of clinical instruments (typically endoscopes or surgical instruments). It is typically available in two co

US‑registered devices57in commercial distribution
Companies10labelers on GUDID
Single‑use98%of device records
Sterile4%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Plasdent Corporation1628%
Ismile Dental Products, Inc.1018%
Henry Schein, Inc.611%
Sml Med-Tech Solutions Limited59%
Cygnus Medical L.L.C.59%
Safco Dental Supply Co.59%
Unipack Medical Corporation47%
Amxor Healthcare Llc35%

Top labelers

CompanyDevicesShare
Plasdent Corporation1628%
Ismile Dental Products, Inc.1018%
Henry Schein, Inc.611%
Sml Med-Tech Solutions Limited59%
Cygnus Medical L.L.C.59%
Safco Dental Supply Co.59%
Unipack Medical Corporation47%
Amxor Healthcare Llc35%
Young Innovations, Inc.24%
Medline Industries, Inc.12%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CeroFrictPlasdentAMXOR Tray CoversCYGNUSDefendUnipackSafco One Sheet Tray CoversiSmileHenry ScheinMedline

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

FDA product codes

CodeNameDevices
NRDUnit, Operative Dental, Accessories14
NRUChair, Dental, Without Operative Unit10
NRDUnit, operative dental, accessories6
NRUCHAIR, DENTAL, WITHOUT OPERATIVE UNIT6
PHTBasin For Endoscope Reprocessing5
PEMDental Barriers And Sleeves5

GMDN & GCC registration

  • GMDN code 64367 · non‑implantable
  • Single‑use 98% · sterile 4% · Rx‑only 0% · OTC 18%
  • 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 instrument tray cover, single-use products are registered in the US?

57 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Instrument tray cover, single-use", from 10 companies. The largest labeler is Plasdent Corporation with 28% of records.

Which FDA product codes apply?

NRD (Unit, Operative Dental, Accessories), NRU (Chair, Dental, Without Operative Unit), NRD (Unit, operative dental, accessories), NRU (CHAIR, DENTAL, WITHOUT OPERATIVE UNIT)

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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