FDA UDI
In Commercial Distribution
🇺🇸 United States
Seventh Generation
DI: 00732913451098
·
Model: Super, with plant-based plastic applicator
·
SEVENTH GENERATION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
6
Pkg Device Count
12
Basic Information
- Brand Name
- Seventh Generation
- Primary DI
- 00732913451098
- Version / Model
- Super, with plant-based plastic applicator
- Catalog Number
- 45109
- Company Name
- SEVENTH GENERATION, INC.
- Labeler DUNS
- 178161212
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2017-04-17
- Public Version
- 5
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 492b63ee-7c5f-486e-af5b-7d22ce5d3543
Device Description
Organic Cotton Comfort Applicator Tampons, Super (plant-based plastic applicator)
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
- No
- 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 |
|---|---|---|---|---|---|---|
| Package | 10732913451095 | GS1 | Case | 12 | Not in Commercial Distribution | 2020-06-30 |
| Primary | 00732913451098 | GS1 | ||||
| Unit of Use | 10732913447999 | GS1 | ||||
| Package | 50732913446433 | GS1 | Box | 2 | Not in Commercial Distribution | 2020-06-30 |
| Package | 10732913446435 | GS1 | Case | 6 | Not in Commercial Distribution | 2020-06-30 |
| Package | 10732913447852 | GS1 | Case | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-211-4279
- [email protected]