FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756371841
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
89-10643
Catalog number
89-10643
Device description
EPIDURAL TRAY PGYBK
Published
2021-05-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
50749756371846PackageGS155In Commercial Distribution
00749756371841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975637184650749756371846
00749756371841007497563718417497563718410749756371841

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
Kit
true
Lot or batch
true
Expiration 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
B098AMS192900Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-19
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10809160527313HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527320HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527344HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527351HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527368HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527399HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527405HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527412HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527443HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527450HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527467HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527474HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527481HalyardAVID MEDICAL, INC.LRO2026-07-17
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10198956418431CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956439887CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956444386CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956462175CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956472105CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956477360CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956477391CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956479845CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956483439CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956488304CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956502437CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956504868CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956507982CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956508149CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16