Identity
- Trade Name
- Sylk FDA UDI
- Generic Name
- Sexual lubricant FDA UDI
- Device Name
- Sylk Personal Lubricant is an intimate moisturizer made with the vine extract of the New Zealand kiwifruit plant harvested from orchards in the Province of Auckland, New Zealand. Through a proprietary extraction process, the natural film‐like lubricant is collected, the composition of which is similar to that of what the body produces. Sylk Personal Lubricant is formulated to be a non‐sterile, non‐greasy, non‐sticky, non‐staining, viscous liquid with a pH range of 4.4 to 4.7 to match the vaginal region for the majority of a women’s cycle. The device is not a contraceptive and does not contain a spermicide. This device is packaged in 3 ounce tubes. FDA UDI
- Model / Reference
- Toro 100 FDA UDI
- Description
- Sylk Personal Lubricant is an intimate moisturizer made with the vine extract of the New Zealand kiwifruit plant harvested from orchards in the Province of Auckland, New Zealand. Through a proprietary extraction process, the natural film‐like lubricant is collected, the composition of which is similar to that of what the body produces. Sylk Personal Lubricant is formulated to be a non‐sterile, non‐greasy, non‐sticky, non‐staining, viscous liquid with a pH range of 4.4 to 4.7 to match the vaginal region for the majority of a women’s cycle. The device is not a contraceptive and does not contain a spermicide. This device is packaged in 3 ounce tubes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00868371000209 FDA UDI
- 510(k) Number
- K152646 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
- Total Volume — 3 Fluid Ounce FDA UDI
Category: Sexual lubricant
Sylk by Toro Management Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K152646 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Toro Management Llc
Sources (1)
- FDA UDI 9d5b24a6-cc6b-4cf3-9d74-09f3324904b0 36 fields · synced May 31, 2026