FDA UDI
In Commercial Distribution
🇺🇸 United States
Natracare
DI: 00782126002006
·
Model: Tampons Super
·
BODYWISE (UK) LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
20
Basic Information
- Brand Name
- Natracare
- Primary DI
- 00782126002006
- Version / Model
- Tampons Super
- Company Name
- BODYWISE (UK) LIMITED
- Labeler DUNS
- 503650061
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 4
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 0e1eecea-4615-4fa4-9d18-b7827a5ee9c8
Device Description
Organic Cotton Tampon, Menstrual, Unscented Super 20 single use tampons per pack
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
- Yes
- 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 | 05019493020001 | GS1 | Carton | 12 | In Commercial Distribution | |
| Primary | 00782126002006 | GS1 | ||||
| Unit of Use | 00782126002001 | GS1 |
Customer Contacts
- Phone
- 855 265 9289
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K914430 | 000 |