FDA UDI
In Commercial Distribution
🇺🇸 United States
DynaCare Organic Tampons, Regular, Cardboard Applicator
DI: 00840117343405
·
Model: 1378
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
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Basic Information
- Brand Name
- DynaCare Organic Tampons, Regular, Cardboard Applicator
- Primary DI
- 00840117343405
- Version / Model
- 1378
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2025-06-05
- Public Version
- 2
- Public Version Date
- 2025-08-18
- Public Version Status
- Update
- Public Device Record Key
- 5c2175f6-1ee5-4b52-9525-523e8ba44e4d
Device Description
Regular: 6-9 G, Super 3-12 G, Super Plus: 12-15 G. Ingredients: 100% Organic Cotton (Wadding), 100% Organic Cotton (Non-Woven), Organic Cotton (Withdrawal Cord), Cardboard (Applicator). Warning: Tampons are associated with Toxic Shock Syndrome (TSS). TSS is a rare but serious disease that may cause death. Read and save the enclosed information.
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
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00810180842075 | GS1 | ||||
| Primary | 00840117343405 | GS1 |