FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756028023
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
31-704
Catalog number
31-704
Device description
WATER SOLUBLE LUBRICANT
Published
2021-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMJLubricant, patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMJLubricant, PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756028023PackageGS130In Commercial Distribution
00749756028028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975602802350749756028023
00749756028028007497560280287497560280280749756028028

GMDN Terms#

Term, Definition table
TermDefinition
General-body orifice lubricant, non-sterileA non-sterile substance intended to be used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.

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
true
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
16936603230999Medical LubricantYangzhou Fartley Medical Instrument Technology Co., LtdKMJ2025-06-23
40080196074199MEDLINEMEDLINE INDUSTRIES, INC.KMJ2025-04-25
17290100666156Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKMJ2025-04-02
00858276007557Sterile Bacteriostatic Lubricating GelMicro-tech UsaKMJ2025-03-05
10850025860489Endoscopy Kit - Basic + GownsMicro-tech UsaKMJ2025-03-04
00850025860079Endoscopy Kit - Basic+Micro-tech UsaKMJ2025-03-03
00850025860222Endoscopy Kit - Compliance+Micro-tech UsaKMJ2025-03-03
00850025860284Endoscopy Kit - ComplianceMicro-tech UsaKMJ2025-03-03
00858276007441Endoscopy Kit - BasicMicro-tech UsaKMJ2025-03-03
00858276007472Endoscopy Kit - UpperMicro-tech UsaKMJ2025-03-03
00858276007502Endoscopy Kit - Set UpMicro-tech UsaKMJ2025-03-03
E23905651Otoferm® CremeDreve Otoplastik GmbHKMJ2024-06-25
34026704921691ARROWTELEFLEX INCORPORATEDKMJ2024-04-08
30810132041762HCSConcordance Healthcare Solutions LLCKMJ2023-10-10
17290100663308Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKMJ2023-09-19
07290100663288Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKMJ2023-09-19
07290100663301Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKMJ2023-09-19
00304040165157Henry ScheinHENRY SCHEIN, INC.KMJ2023-07-31
00304040165164Henry ScheinHENRY SCHEIN, INC.KMJ2023-07-31
20326053104835Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.KMJ2023-06-29
20326053104842Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.KMJ2023-06-29
20326053104859Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.KMJ2023-06-29
05030267124381OPTILUBE BOX OF 150 SACHETSIntersurgical IncorporatedKMJ2023-06-15
30810132040642HCSConcordance Healthcare Solutions LLCKMJ2023-04-07
00850047788115Oto Ease 12pk Display BoxWestone Laboratories, Inc.KMJ2023-03-02
00850047788122Oto-Ease 1/2oz bottle 1 packWestone Laboratories, Inc.KMJ2023-03-02
00850047788139Oto-Ease 1/2-oz bottles 5/pkWestone Laboratories, Inc.KMJ2023-03-02
00850047788146Oto-Ease Single Dose - 100/pkWestone Laboratories, Inc.KMJ2023-03-02
40080196291572MedlineMEDLINE INDUSTRIES, INC.KMJ2023-02-04
20326053118535Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.KMJ2023-01-13