Identity
- Trade Name
- Astroglide Organix Gel FDA UDI
- Generic Name
- Sexual lubricant FDA UDI
- Device Name
- Astroglide Organix is a personal lubricant for penile and/or vaginal 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. It is not compatible with polyisoprene, and polyurethane condoms. FDA UDI
- Model / Reference
- 015594011660 FDA UDI
- Description
- Astroglide Organix is a personal lubricant for penile and/or vaginal 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. It is not compatible with polyisoprene, and polyurethane condoms. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00015594011660 FDA UDI
- FDA Product Code
- NUC FDA UDI
- GMDN Term
- Sexual lubricant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 85 Gram FDA UDI
Category: Sexual lubricant
Astroglide Organix Gel by Biofilm, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biofilm, Inc
Sources (1)
- FDA UDI 78327ec4-d1ab-4237-957e-ee453c9db58d 36 fields · synced Jun 8, 2026