UDI device identifier

Astroglide X Premium Silicone Gel Personal Lubricant 015594011752

UDI device identifier 00015594011752 · BIOFILM, INC

Key facts

Primary DI 00015594011752
Brand name Astroglide X Premium Silicone Gel Personal Lubricant
Version or model 015594011752
Company BIOFILM, INC
DUNS number 790780258
Product code NUC
GMDN term Sexual lubricant
Premarket submission K163395
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date May 7, 2019
Version date Aug 7, 2020
Description Astroglide X Premium Silicone Gel is a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate activity and supplement the body’s natural lubrication. This product is compatible with natural rubber latex…

At a glance

  • None MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 1,000+ GUDID devices with this product code

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

About UDI device identifiers (GUDID)

The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.

Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date:

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