FDA UDI
In Commercial Distribution
🇺🇸 United States
INCOGNITO
DI: 00069207994451
·
Model: 10006612
·
Fempro Consumer Products ULC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
34
Basic Information
- Brand Name
- INCOGNITO
- Primary DI
- 00069207994451
- Version / Model
- 10006612
- Company Name
- Fempro Consumer Products ULC
- Labeler DUNS
- 253562201
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 34
- Record Status
- Published
- Publish Date
- 2023-01-24
- Public Version
- 1
- Public Version Date
- 2023-02-01
- Public Version Status
- New
- Public Device Record Key
- 3e844866-4aff-4ffb-897d-62875a73fc94
Device Description
PANTILINER EX LONG UNSCENTED 34 CT
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HHD | Pad, Menstrual, Unscented | Obstetrics/Gynecology | 884.5435 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40545 | Menstrual pad, unscented | A non-deodorized, feminine hygiene product (a pad) that is held in place externally to absorb menstrual or other vaginal discharge. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10069207994458 | GS1 | CASE | 12 | In Commercial Distribution | |
| Primary | 00069207994451 | GS1 | ||||
| Unit of Use | 00006920799444 | GS1 |