FDA UDI
In Commercial Distribution
🇺🇸 United States
Vaginal Applicator APPLISIL
DI: 03701225740845
·
Model: Applicator 2.5g - Flowpack by 1
·
UNION PLASTIC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vaginal Applicator APPLISIL
- Primary DI
- 03701225740845
- Version / Model
- Applicator 2.5g - Flowpack by 1
- Catalog Number
- 1ASV1155
- Company Name
- UNION PLASTIC
- Labeler DUNS
- 381128396
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-07
- Public Version
- 1
- Public Version Date
- 2024-03-15
- Public Version Status
- New
- Public Device Record Key
- 529c6173-5eda-4514-b5ef-7766100a687e
Device Description
Medical Device with Measuring Function. Use for the dosage and administration of drugs to human.
Device Characteristics
- Single Use
- No
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KYX | Dispenser, Liquid Medication | General Hospital | 880.6430 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32652 | Vaginal applicator, reusable | A device designed to apply medication to the vagina. It is typically a hand-held bulb, pump, or injector used to introduce medicated powder or other substances into the vagina either directly or through an open speculum. It is typically used to treat vaginitis but can be used for other forms of vaginal treatment. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03701225740845 | GS1 |