FDA UDI
In Commercial Distribution
🇺🇸 United States
pjur WOMAN Nude
DI: 00827160114367
·
Model: pjur WOMAN Nude 10 ml - USA
·
Pjur Group Luxembourg SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- pjur WOMAN Nude
- Primary DI
- 00827160114367
- Version / Model
- pjur WOMAN Nude 10 ml - USA
- Catalog Number
- 13790-02
- Company Name
- Pjur Group Luxembourg SA
- Labeler DUNS
- 400744553
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-23
- Public Version
- 1
- Public Version Date
- 2024-05-31
- Public Version Status
- New
- Public Device Record Key
- 06c172f1-696a-4072-b757-70ba0d2c6772
Device Description
Water-based Personal Lubricant Mini-Collection USA
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00827160114367 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200730 | 000 |