FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756168682
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
77-300741
Device description
Control Syringe, 10 cc, MLL
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
DXTINJECTOR AND SYRINGE, ANGIOGRAPHIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXTInjector And Syringe, AngiographicCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756168682PackageGS125In Commercial Distribution
00749756168687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975616868250749756168682
00749756168687007497561686877497561686870749756168687

GMDN Terms#

Term, Definition table
TermDefinition
Angiographic syringeA sterile, manually-operated device consisting of a barrel (cylinder) with plunger intended to be used for the administration of a contrast medium into the heart, great vessels, and coronary arteries to study the heart and vessels under x-ray photography. It may in addition be intended for introduction of other fluids (e.g., saline). It is not intended to be used with a contrast medium injection system. 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
false
HCT/P
false
Kit
false
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
10841716102704ACIST VeraPro HiFi 165ACIST MEDICAL SYSTEMS, INC.DXT2026-05-26
10841716102728ACIST VeraPro FLX 165ACIST MEDICAL SYSTEMS, INC.DXT2026-05-26
10841716102742ACIST VeraPro S100 Multi-Use SyringeACIST MEDICAL SYSTEMS, INC.DXT2026-05-26
10841716102773ACIST VeraPro S100 LV1 Low-Viscosity SyringeACIST MEDICAL SYSTEMS, INC.DXT2026-05-26
10841716102803ACIST VeraPro AMT Auto-Manifold and TransducerACIST MEDICAL SYSTEMS, INC.DXT2026-05-26
00884450435533Merit Medical®Merit Medical Systems, Inc.DXT2026-05-23
10884450121433Merit Medical®Merit Medical Systems, Inc.DXT2026-01-13
00616258020419MEDRAD® Mark 7 Arterion Injection SystemBayer Medical Care Inc.DXT2025-12-19
40616258021247MEDRAD® VFLOW Sterile Disposable Hand ControllerBayer Medical Care Inc.DXT2025-12-19
00616258025186MEDRAD® Stellant CT Injection SystemBayer Medical Care Inc.DXT2025-12-10
00616258027333MEDRAD® Stellant FLEX CT Injection System with Certegra® WorkstationBayer Medical Care Inc.DXT2025-12-10
49345390003538MEDRAD® Centargo Patient LineIMAXEON PTY LTDDXT2025-12-10
26938327901909DeRoyalShenzhen Boon Medical Supply Co., Ltd.DXT2025-11-28
26938327909189Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2025-11-17
16938327909199Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2025-11-17
16938327909205Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2025-11-17
26945764400148AntmedShenZhen Antmed Co., LtdDXT2025-09-17
26945764400162AntmedShenZhen Antmed Co., LtdDXT2025-09-17
50628725095078MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095085MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095108MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095160MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095177MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095184MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095191MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095214MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
09345390003356MEDRAD® Centargo CT Injection SystemIMAXEON PTY LTDDXT2025-08-18
00628725095066MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-08-15
50628725095153MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-08-15
50628725095207MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-08-15