FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756033756
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
31-938
Device description
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
50749756033751PackageGS150In Commercial Distribution
00749756033756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975603375150749756033751
00749756033756007497560337567497560337560749756033756

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
00749756401944DeRoyal46-LT5S-0546-LT5S-052026-05-14
00749756998857DeRoyal99-021399-02132019-11-09
00749756998864DeRoyal99-021499-02142019-11-09
00749756998871DeRoyal99-021599-02152019-11-09
00749756998888DeRoyal99-021699-02162019-11-09
00749756998901DeRoyal99-021799-02172019-11-09
00749756998918DeRoyal99-021899-02182019-11-09
00749756998925DeRoyal99-021999-02192019-11-09
00749756998956DeRoyal99-022099-02202019-11-09
00749756998963DeRoyal99-022199-02212019-11-09
00749756998970DeRoyal99-022299-02222019-11-09
00749756998642DeRoyal99-021199-02112021-05-07
00749756401685DeRoyalNP-7DAYKITUTSNP-7DAYKITUTS2026-04-02
00749756401951DeRoyal46-LT20S-0446-LT20S-042026-04-02
00749756401968DeRoyal46-LT19S-0446-LT19S-042026-04-02
00749756402033DeRoyal46-LB5546-LB552026-04-02
00749756879699DeRoyal1104SPP1104SPP2026-04-02
00749756879705DeRoyal1104MPP1104MPP2026-04-02
00749756879712DeRoyal1104LPP1104LPP2026-04-02
00749756879729DeRoyal1104XLPP1104XLPP2026-04-02

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
00749756026512DeRoyalDEROYAL 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