FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756891061
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
89-8940
Device description
MAJOR LITHOTOMY PACK
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756891061PackageGS12In Commercial Distribution
00749756891066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975689106150749756891061
00749756891066007497568910667497568910660749756891066

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
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10198956386303CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956387959CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956420076CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956425996CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956457119CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956459878CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956462007CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956462151CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956473478CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956475427CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956483675CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956485068CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956490956CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956491496CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
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10198956491908CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956491953CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956492219CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956492615CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956493902CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956494435CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956494558CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956496996CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956497375CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956497450CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956497696CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956497900CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09