FDA UDI
In Commercial Distribution
🇺🇸 United States
Turn ON Silicone Personal Lubricant
DI: 00716222561044
·
Model: 56104
·
Trigg Laboratories, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Turn ON Silicone Personal Lubricant
- Primary DI
- 00716222561044
- Version / Model
- 56104
- Catalog Number
- 56104
- Company Name
- Trigg Laboratories, Inc.
- Labeler DUNS
- 618973077
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-15
- Public Version
- 1
- Public Version Date
- 2021-11-23
- Public Version Status
- New
- Public Device Record Key
- 06b86374-003f-4541-ac5c-d49fd23386ad
Device Description
Turn ON Silicone 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, polyisoprene, and polyurethane condoms.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NUC | Lubricant, Personal | Obstetrics/Gynecology | 884.5300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34131 | Vaginal lubricant | A non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00716222561044 | GS1 |
Customer Contacts
- Phone
- 7029574400
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 56 – 86 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit