FDA UDI
In Commercial Distribution
🇺🇸 United States
ID Xtreme 8 fl oz Tube Amazon (Condom Pros Seller Central FBA label)
DI: 00761236902611
·
Model: ID Xtreme 8 fl oz Tube Amazon (Condom Pros Seller Central FBA label)
·
WESTRIDGE LABORATORIES INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ID Xtreme 8 fl oz Tube Amazon (Condom Pros Seller Central FBA label)
- Primary DI
- 00761236902611
- Version / Model
- ID Xtreme 8 fl oz Tube Amazon (Condom Pros Seller Central FBA label)
- Catalog Number
- IDD114X1
- Company Name
- WESTRIDGE LABORATORIES INCORPORATED
- Labeler DUNS
- 879057065
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-12
- Public Version
- 1
- Public Version Date
- 2023-04-20
- Public Version Status
- New
- Public Device Record Key
- 43dea372-982b-412a-9234-4faaa1face78
Device Description
ID Xtreme 8 fl oz Tube Amazon (Condom Pros Seller Central FBA label)
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 |
|---|---|---|---|---|
| 60412 | Sexual lubricant | A substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30761236902612 | GS1 | 12 | In Commercial Distribution | ||
| Primary | 00761236902611 | GS1 |
Customer Contacts
- Phone
- 7142599400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051295 | 000 |