FDA.report

DeRoyal

Primary DI
50749756908752
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
77-401059
Device description
SARASOTA MANIFOLD KIT
Published
2016-12-29
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

Related Records

Contact Domains

Product Codes

CodeName
DXTINJECTOR AND SYRINGE, ANGIOGRAPHIC

Product Code Classifications

CodeDeviceSpecialtyClass
DXTInjector And Syringe, AngiographicCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50749756908752PackageGS125In Commercial Distribution
00749756908757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975690875250749756908752
00749756908757007497569087577497569087570749756908757

GMDN Terms

TermDefinition
Angiography kitA collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. This is a single-use device.

Sterilization Methods

Method

Contacts

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 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

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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
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50628725095191MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
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09345390003356MEDRAD® Centargo CT Injection SystemIMAXEON PTY LTDDXT2025-08-18
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50628725095122MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-08-07
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