Home GUDID 50749756026517 DeRoyal
Primary DI 50749756026517
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
Rx false
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name FHX JELLY, LUBRICATING, FOR TRANSURETHRAL SURGICAL INSTRUMENT
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FHX Jelly, Lubricating, For Transurethral Surgical Instrument Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 50749756026517 Package GS1 50 In Commercial Distribution 00749756026512 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 50749756026517 50749756026517 00749756026512 00749756026512 749756026512 0749756026512
GMDN Terms# Term, Definition table Term Definition Urinary tract-access lubricant, non-medicated, non-sterile A non-sterile 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.
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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10197344007035 APLICARE MEDLINE INDUSTRIES, INC. FHX 2024-01-23 30197344007039 APLICARE MEDLINE INDUSTRIES, INC. FHX 2024-01-23 10197344007042 APLICARE MEDLINE INDUSTRIES, INC. FHX 2023-10-31 30197344007046 APLICARE MEDLINE INDUSTRIES, INC. FHX 2023-10-31 00842209101870 NAR Kit NORTH AMERICAN RESCUE, LLC FHX 2018-09-14 00618407002802 Aplicare Lubricating Jelly APLICARE, INC. FHX 2017-08-17 00618407002819 Aplicare Lubricating Jelly APLICARE, INC. FHX 2017-08-17 10884389706343 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FHX 2016-09-29 00749756026512 DeRoyal DEROYAL INDUSTRIES, INC. FHX 2016-09-12 00749756033756 DeRoyal DEROYAL INDUSTRIES, INC. FHX 2016-09-12 00749756770378 DeRoyal DEROYAL INDUSTRIES, INC. FHX 2016-09-12 50749756033751 DeRoyal DEROYAL INDUSTRIES, INC. FHX 2016-09-12 50749756770373 DeRoyal DEROYAL INDUSTRIES, INC. FHX 2016-09-12
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