FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Daye
DI: 05060994741247
·
Model: FG-TMP-MM-REF180018
·
TAMPON INNOVATIONS LTD OOD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
36
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Basic Information
- Brand Name
- Daye
- Primary DI
- 05060994741247
- Version / Model
- FG-TMP-MM-REF180018
- Company Name
- TAMPON INNOVATIONS LTD OOD
- Labeler DUNS
- 524392286
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 36
- Record Status
- Published
- Publish Date
- 2024-07-27
- Public Version
- 2
- Public Version Date
- 2025-05-23
- Public Version Status
- Update
- Public Device Record Key
- f64fd46e-1a68-4bfa-b3f7-21d188dccb36
- Distribution End Date
- 2025-01-09
Device Description
Refill 18 Coated Regular and 18 Organic Cotton Regular Tampons
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | Obstetrics/Gynecology | 884.5470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35694 | Menstrual tampon, unscented | A non-deodorized plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual blood 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 55060994741242 | GS1 | ||||
| Primary | 05060994741247 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223883 | 000 |