FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756026512
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
31-702
Device description
Water Soluble Lubricant
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FHXJELLY, LUBRICATING, FOR TRANSURETHRAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHXJelly, Lubricating, For Transurethral Surgical InstrumentGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756026517PackageGS150In Commercial Distribution
00749756026512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975602651750749756026517
00749756026512007497560265127497560265120749756026512

GMDN Terms#

Term, Definition table
TermDefinition
Urinary tract-access lubricant, non-medicatedA substance intended to be used exclusively as a lubricant to facilitate the introduction/manipulation of a device (e.g., cystoscope, catheter, surgical instrument) in the urinary tract, via endoscopic access through the urethra or percutaneous suprapubic catheterization; it does not contain a pharmaceutical. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756402699DeRoyal25-1104EU25-1104EU2026-07-22
00749756402705DeRoyal25-1104EUN25-1104EUN2026-07-22
00749756402750DeRoyal25-1401YEU25-1401YEU2026-07-22
00749756402767DeRoyal25-1403EU25-1403EU2026-07-22
00749756402781DeRoyal25-1702EU25-1702EU2026-07-22
00749756402798DeRoyal25-1702EUN25-1702EUN2026-07-22
00749756402910DeRoyal25-0403EUN25-0403EUN2026-07-22
00749756402545DeRoyal25-0103EU25-0103EU2026-07-08
00749756402552DeRoyal25-0103EUN25-0103EUN2026-07-08
00749756402569DeRoyal25-0104EU25-0104EU2026-07-08
00749756402576DeRoyal25-0104EUN25-0104EUN2026-07-08
00749756402583DeRoyal25-0105EU25-0105EU2026-07-08
00749756402590DeRoyal25-0108EU25-0108EU2026-07-08
00749756402606DeRoyal25-0201EU25-0201EU2026-07-08
00749756402613DeRoyal25-0401EU25-0401EU2026-07-08
00749756402620DeRoyal25-0401EUN25-0401EUN2026-07-08
00749756402637DeRoyal25-0402EU25-0402EU2026-07-08
00749756402644DeRoyal25-0402EUN25-0402EUN2026-07-08
00749756402651DeRoyal25-0403EU25-0403EU2026-07-08
00749756402675DeRoyal25-0801EU25-0801EU2026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344007035APLICAREMEDLINE INDUSTRIES, INC.FHX2024-01-23
30197344007039APLICAREMEDLINE INDUSTRIES, INC.FHX2024-01-23
10197344007042APLICAREMEDLINE INDUSTRIES, INC.FHX2023-10-31
30197344007046APLICAREMEDLINE INDUSTRIES, INC.FHX2023-10-31
00842209101870NAR KitNORTH AMERICAN RESCUE, LLCFHX2018-09-14
00618407002802Aplicare Lubricating JellyAPLICARE, INC.FHX2017-08-17
00618407002819Aplicare Lubricating JellyAPLICARE, INC.FHX2017-08-17
10884389706343Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FHX2016-09-29
00749756033756DeRoyalDEROYAL INDUSTRIES, INC.FHX2016-09-12
00749756770378DeRoyalDEROYAL INDUSTRIES, INC.FHX2016-09-12
50749756026517DeRoyalDEROYAL INDUSTRIES, INC.FHX2016-09-12
50749756033751DeRoyalDEROYAL INDUSTRIES, INC.FHX2016-09-12
50749756770373DeRoyalDEROYAL INDUSTRIES, INC.FHX2016-09-12