FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756907953
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
89-9172
Device description
GYN LAP PACK
Published
2016-09-24
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
50749756907953PackageGS18In Commercial Distribution
00749756907958PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975690795350749756907953
00749756907958007497569079587497569079580749756907958

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
50749756033140DeRoyal10-513010-51302023-01-31
50749756392490DeRoyalNP-6006UNP-6006U2026-01-22
50749756397808DeRoyalNP-0080LMDNP-0080LMD2026-01-22
00749756401258DeRoyalSTM2000STM20002026-01-22
50749756401352DeRoyalM60-AP500M60-AP5002026-01-22
50749756401376DeRoyalM60-AP600M60-AP6002026-01-22
50749756401383DeRoyalM60-AP601M60-AP6012026-01-22
50749756401390DeRoyalM60-AP602M60-AP6022026-01-22
50749756401482DeRoyal46-LT19S-01B46-LT19S-01B2026-01-22
50749756401437DeRoyalM70-200PM70-200P2026-01-01
50749756401444DeRoyalM70-200CM70-200C2026-01-01
50749756401451DeRoyalM70-200CNWM70-200CNW2026-01-01
50749756401468DeRoyalM70-200PNWM70-200PNW2026-01-01
50749756394418DeRoyal71-080571-08052025-08-13
50749756396641DeRoyalPH81-010400PH81-0104002025-08-13
50749756397853DeRoyalPH81-020409PH81-0204092025-08-13
50749756397860DeRoyalPH81-020412PH81-0204122025-08-13
00749756399333DeRoyal1-524A-01-CHO1-524A-01-CHO2025-07-30
00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
00749756399357DeRoyal1-524A-03-CHO1-524A-03-CHO2025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956445673CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956446649CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956457799CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956458000CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956465992CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956466036CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956467354CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956468092CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956473003CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956477155CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956477186CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956478466CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956480704CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956483156CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956484535CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956485327CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956486898CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956488625CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956489455CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10809160521786HalyardAVID MEDICAL, INC.OHD2026-05-22
50198956314687CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956374148CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956382433CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956399301CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956418194CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956425581CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24