FDA UDI
In Commercial Distribution
🇺🇸 United States
pjur BACK DOOR Moisturizing
DI: 00827160116781
·
Model: pjur BACK DOOR Moisturizing 30ml - USA
·
Pjur Group Luxembourg SA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- pjur BACK DOOR Moisturizing
- Primary DI
- 00827160116781
- Version / Model
- pjur BACK DOOR Moisturizing 30ml - USA
- Catalog Number
- 14063-02
- Company Name
- Pjur Group Luxembourg SA
- Labeler DUNS
- 400744553
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-16
- Public Version
- 1
- Public Version Date
- 2025-04-24
- Public Version Status
- New
- Public Device Record Key
- 93b62e6b-bc89-4b44-b566-c0649d6ac065
Device Description
Water-based Personal Lubricant
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
- 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 | 10827160116788 | GS1 | pack | 12 | In Commercial Distribution | |
| Primary | 00827160116781 | GS1 | ||||
| Package | 40827160116789 | GS1 | case | 28 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200527 | 000 |