DEVICE: Astroglide X Silicone Liquid (00015594000046)
Device Identifier (DI) Information
Astroglide X Silicone Liquid
015594000046
In Commercial Distribution
N/A
BIOFILM, INC
015594000046
In Commercial Distribution
N/A
BIOFILM, INC
Astroglide® X Silicone Personal Lubricant 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 condoms. This product is not compatible with polyisoprene and polyurethane condoms.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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Yes | |
No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
60412 | Sexual lubricant |
A substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NUC | Lubricant, Personal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 70 and 77 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 12 Fluid Ounce |
Device Record Status
a7ea7b2a-c8f0-4b8d-9e1b-9353c47f733b
July 14, 2025
1
July 05, 2025
July 14, 2025
1
July 05, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-431-2610
sircmrof@combe.com
sircmrof@combe.com