FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756954792
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
EZ2-R
Device description
Rigid Adapter1.75DiaX1.5Lg Clear Anodize
Published
2018-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTALight, surgical, accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTALight, Surgical, AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756954797PackageGS11In Commercial Distribution
00749756954792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975695479750749756954797
00749756954792007497569547927497569547920749756954792

GMDN Terms#

Term, Definition table
TermDefinition
Instrument/equipment drape, single-use, sterileA sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756402545DeRoyal25-0103EU25-0103EU2026-07-08
00749756402552DeRoyal25-0103EUN25-0103EUN2026-07-08
00749756402569DeRoyal25-0104EU25-0104EU2026-07-08
00749756402576DeRoyal25-0104EUN25-0104EUN2026-07-08
00749756402583DeRoyal25-0105EU25-0105EU2026-07-08
00749756402590DeRoyal25-0108EU25-0108EU2026-07-08
00749756402606DeRoyal25-0201EU25-0201EU2026-07-08
00749756402613DeRoyal25-0401EU25-0401EU2026-07-08
00749756402620DeRoyal25-0401EUN25-0401EUN2026-07-08
00749756402637DeRoyal25-0402EU25-0402EU2026-07-08
00749756402644DeRoyal25-0402EUN25-0402EUN2026-07-08
00749756402651DeRoyal25-0403EU25-0403EU2026-07-08
00749756402675DeRoyal25-0801EU25-0801EU2026-07-08
00749756402682DeRoyal25-0802EU25-0802EU2026-07-08
00749756402712DeRoyal25-1108EU25-1108EU2026-07-08
00749756402729DeRoyal25-1108EUN25-1108EUN2026-07-08
00749756402736DeRoyal25-1401EU25-1401EU2026-07-08
00749756402743DeRoyal25-1401EUN25-1401EUN2026-07-08
00749756402774DeRoyal25-1403EUN25-1403EUN2026-07-08
00749756402538DeRoyal25-0101EUN25-0101EUN2026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918170732InvenioGRI Medical & Electronic Technology Co., Ltd.FTA2026-04-17
10748426144560Medline-MicrotekMicrotek Medical LLCFTA2026-02-18
00748426142934Skytron®Microtek Medical LLCFTA2026-02-05
00748426145027NAMicrotek Medical LLCFTA2026-02-05
20748426262704Medline-MicrotekMicrotek Medical LLCFTA2026-01-05
80080196761844MEDLINEMEDLINE INDUSTRIES, INC.FTA2025-11-04
10724995245457HexaLuxSTERIS CORPORATIONFTA2025-05-05
20885380184113CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
20885380184120CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
20885380184137CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
50885380184787CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
00724995203399NASTERIS CORPORATIONFTA2023-11-17
10197344006915MedlineMEDLINE INDUSTRIES, INC.FTA2023-11-05
50885380183001CARDINAL HEALTHCardinal Health 200, LLCFTA2023-08-11
50885380182998CARDINAL HEALTHCardinal Health 200, LLCFTA2023-08-11
16931918117362AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2023-07-20
16931918159256AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2022-11-26
16931918133201AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2022-11-22
16931918196565AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2022-11-22
00748426118526Skytron Lite-LokMicrotek Medical LLCFTA2022-08-08
10193489003093MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.FTA2021-11-03
10193489003109MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.FTA2021-11-03
10193489005875MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.FTA2021-11-03
00749756725538DeRoyalDEROYAL INDUSTRIES, INC.FTA2021-08-23
G018DLH010Physician's ChoiceSupply Line International Medical, LLCFTA2021-08-05
16931918155524AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2021-04-22
16931918167046AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2021-04-22
16931918173153AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2021-04-22
16931918127309AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2021-03-08
16931918123493B.braunGRI Medical & Electronic Technology Co., Ltd.FTA2021-02-27