FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756239566
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
89-2176
Device description
LAP TUBAL VALUE SET
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
50749756239566PackageGS15In Commercial Distribution
00749756239561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975623956650749756239566
00749756239561007497562395617497562395610749756239561

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
00749756389181DeRoyal81-1020SU81-1020SU2026-09-21
00749756389204DeRoyal81-1020REF81-1020REF2026-09-21
00749756399258DeRoyal46-326XBNS46-326XBNS2026-09-21
00749756400442DeRoyal77-40111877-4011182026-09-21
00749756985475DeRoyalNP-790NP-7902026-09-21
00749756985963DeRoyalNP-7300-01NP-7300-012026-09-21
00749756985994DeRoyalNP-7300NP-73002026-09-21
00749756986250DeRoyalNP-7300NNP-7300N2026-09-21
00749756394666DeRoyal47-820KG47-820KG2026-09-18
00749756397193DeRoyal47-813KG-0147-813KG-012026-09-18
00749756397339DeRoyal15410002154100022026-09-18
00749756397346DeRoyal15410003154100032026-09-18
00749756400800DeRoyal32-219532-21952026-09-18
00749756401289DeRoyalNP-7000-GPSNP-7000-GPS2026-09-18
00749756401678DeRoyal13-809A-01-COSM13-809A-01-COSM2026-09-18
00749756401692DeRoyalNP-6007U-01NP-6007U-012026-09-18
00749756401708DeRoyal46-LB19546-LB1952026-09-18
00749756401715DeRoyal46-LB38546-LB3852026-09-18
00749756401739DeRoyalM60-SF510TM60-SF510T2026-09-18
00749756401746DeRoyalNP-120UNP-120U2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS186920Aligned Medical SolutionsAligned Medical SolutionsOHD2026-09-26
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10198956547414CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956557109CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956567733CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956570764CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956587991CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956333758CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956346222CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956507807CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956539372CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956543423CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956567689CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956567801CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956570115CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956577848CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956579613CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956580558CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956581043CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956581975CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956583436CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956589216CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956439610CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-21
10198956521452CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-21
10198956534278CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-21
10198956571488CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-21
10198956576360CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-21
B098AMS197460Aligned Medical SolutionsAligned Medical SolutionsOHD2026-09-18