FDA UDI
In Commercial Distribution
🇺🇸 United States
Oi
DI: 09421904034501
·
Model: BCT Super
·
ORGANIC INITIATIVE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
16
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Basic Information
- Brand Name
- Oi
- Primary DI
- 09421904034501
- Version / Model
- BCT Super
- Company Name
- ORGANIC INITIATIVE CORPORATION
- Labeler DUNS
- 081157098
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 16
- Record Status
- Published
- Publish Date
- 2023-12-20
- Public Version
- 1
- Public Version Date
- 2023-12-28
- Public Version Status
- New
- Public Device Record Key
- 2c680c0c-df22-4e11-a908-91675e426d8b
Device Description
Oi Organic Cotton Tampons with BioCompact Applicator, Super 16s
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 | 09421904034532 | GS1 | Master Case | 12 | In Commercial Distribution | |
| Primary | 09421904034501 | GS1 | ||||
| Package | 09421034090217 | GS1 | Multipack | 2 | In Commercial Distribution | |
| Package | 09421034090019 | GS1 | Multipack | 4 | In Commercial Distribution | |
| Unit of Use | 09421034093317 | GS1 |