FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756733200
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
89-7047
Device description
C-SECTION 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
OHMCesarean section tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHMCesarean Section TrayObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756733200PackageGS13In Commercial Distribution
00749756733205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975673320050749756733200
00749756733205007497567332057497567332050749756733205

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
10198956388345CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956457683CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
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10198956479654CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956479760CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956483026CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956484924CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956485181CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956485495CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956485532CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956485631CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956488632CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956488786CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
50198956424560CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-24
50198956427455CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-24
50198956337099CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956343434CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956387506CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956402094CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956410181CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956412758CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956414080CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956418002CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956419825CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956420838CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956424324CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956366082CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-19
50198956373592CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-19
50198956376395CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-19
50198956390216CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-19