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Astroglide TTC - Trying to Conceive
FDA UDIClass II (US FDA UDI)
by Biofilm, Inc
Identity
- Trade Name
- Astroglide TTC - Trying to Conceive FDA UDI
- Generic Name
- Sexual lubricant FDA UDI
- Device Name
- Astroglide TTC is a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. Astroglide TTC comes in 8 individually wrapped 5 mL pre-filled single use applicators. Astroglide TTC is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. Astroglide TTC is compatible with natural rubber latex, polyisoprene and polyurethane condoms. FDA UDI
- Model / Reference
- 015594011226 FDA UDI
- Description
- Astroglide TTC is a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. Astroglide TTC comes in 8 individually wrapped 5 mL pre-filled single use applicators. Astroglide TTC is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. Astroglide TTC is compatible with natural rubber latex, polyisoprene and polyurethane condoms. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00015594011226 FDA UDI
- 510(k) Number
- K141132 FDA UDI
- FDA Product Code
- PEB 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
Yes
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
- Total Volume — 1.4 Fluid Ounce FDA UDI
Category: Sexual lubricant
Astroglide TTC - Trying to Conceive 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 a0d91872-f613-4f34-94fc-38a6476071a1 37 fields · synced May 30, 2026