FDA UDI
In Commercial Distribution
🇺🇸 United States
Trojan HotSpot Vibrating Ring and 1 Ultra Thin Condom
DI: 00022600906674
·
Model: 00022600906674
·
CHURCH & DWIGHT CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Trojan HotSpot Vibrating Ring and 1 Ultra Thin Condom
- Primary DI
- 00022600906674
- Version / Model
- 00022600906674
- Company Name
- CHURCH & DWIGHT CO., INC.
- Labeler DUNS
- 001211952
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-10
- Public Version
- 1
- Public Version Date
- 2019-07-18
- Public Version Status
- New
- Public Device Record Key
- de2fd260-2707-407b-9bc9-5615624fbd3a
Device Description
One Trojan Hot Spot Vibrating Ring designed to provide spot on pleasure. 1 Trojan Ultra Thin Latex Condom for Contraception Plus STI Protection.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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 |
|---|---|---|---|---|
| HIS | CONDOM | Obstetrics/Gynecology | 884.5300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45138 | Basic male condom, Hevea-latex | A Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00022600906674 | GS1 |
Customer Contacts
- Phone
- +1(800)833-9532
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K901192 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- For the Condom: Avoid exposure to direct sunlight or storage for prolonged periods at temperatures above 100 Degrees F.