FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756874125
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
89-8731
Device description
LAP GYN TRAY
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
OHDGynecological laparoscopic kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHDGynecological Laparoscopic KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756874125PackageGS16In Commercial Distribution
00749756874120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975687412550749756874125
00749756874120007497568741207497568741200749756874120

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological 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
true
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
10198956313576CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956333888CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956428003CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956467446CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956484467CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956485150CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956492349CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956497634CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956497672CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956504950CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956505773CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956509290CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956515543CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956525054CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956527423CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956528079CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956477001CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-06
10198956505612CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-06
10198956509344CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-06
10198956525184CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-06
10198956526747CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-06
10198956318595CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-23
10198956488496CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-23
10198956510227CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-23
10198956511088CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-23
10198956515253CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-23
10198956436626CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956465176CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956467651CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956488922CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08