FDA device listing

Durex Juicy Play Cherry Flavored Personal Lubricant,Durex Juicy Play Cherry Flavored Sweeten Up Your Play Personal…

FDA device listing 1324472877 · Reckitt Benckiser LLC

Key facts

Proprietary names Durex Juicy Play Cherry Flavored Personal Lubricant,Durex Juicy Play Cherry Flavored Sweeten Up Your Play Personal Lubricant,Durex Massage Lube & Gel Aloe Vera Personal Lubricant,Durex Massage Lube & Gel Ylang Ylang Personal Lubricant,Durex Touch & Play Aloe Vera Massage & Pleasure Personal Lubricant,Durex Touch & Play Ylang Ylang Massage & Pleasure Personal Lubricant
Owner/operator Reckitt Benckiser LLC
Owner/operator number 9004884
Premarket submissions K213400
Product codes NUC
Device names NUC - Lubricant, Personal
Device class Class II
Classification regulations (21 CFR) 884.5300
Review panels Obstetrics/Gynecology
Registered establishments Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd., Reckitt Benckiser LLC, SSL MANUFACTURING (THAILAND) LTD.
Establishment registrations 2531449, 3003071219, 3010164364, 3011015568
FEI numbers 3003071219, 3003979157, 3008264702, 3011015568
Establishment operations Complaint File Establishment, Manufacturer, Repackager/Relabeler, Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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