UDI device identifier

Astroglide Ultra Gentle Gel 015594011035

UDI device identifier 00015594011035 · BIOFILM, INC

Key facts

Primary DI 00015594011035
Brand name Astroglide Ultra Gentle Gel
Version or model 015594011035
Company BIOFILM, INC
DUNS number 790780258
Product code NUC
GMDN term Sexual lubricant
Premarket submission K220355
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date Jun 6, 2023
Version date Jun 14, 2023
Description Astroglide Ultra Gentle Gel is a personal lubricant for penile, vaginal, and/or anal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and…

At a glance

  • 1–9 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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