FDA UDI
In Commercial Distribution
🇺🇸 United States
Playtex
DI: 00078300028017
·
Model: 02801
·
EDGEWELL PERSONAL CARE BRANDS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Playtex
- Primary DI
- 00078300028017
- Version / Model
- 02801
- Company Name
- EDGEWELL PERSONAL CARE BRANDS, LLC
- Labeler DUNS
- 151179769
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-01
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- a2d497e4-0e84-4236-83ac-98d6d1304f47
Device Description
Playtex Simply Gentle Glide 20ct Sup Unsc Tamp
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
- MR Safe
- 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 | 10078300028014 | GS1 | 224 | In Commercial Distribution | ||
| Primary | 00078300028017 | GS1 |