FDA UDI
In Commercial Distribution
🇺🇸 United States
UroDapter®/MID-II
DI: 05996617000050
·
Model: 17001
·
PHARMICO MEDICAL Korlátolt Felelősségű Társaság
Product Codes
1
GMDN Terms
1
Identifiers
6
Pkg Device Count
1
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Basic Information
- Brand Name
- UroDapter®/MID-II
- Primary DI
- 05996617000050
- Version / Model
- 17001
- Company Name
- PHARMICO MEDICAL Korlátolt Felelősségű Társaság
- Labeler DUNS
- 860789069
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-25
- Public Version
- 1
- Public Version Date
- 2025-09-02
- Public Version Status
- New
- Public Device Record Key
- a6077507-22df-4d48-a8ca-6c995cbec24b
Device Description
Urological syringe adapter replacing the traditional catheter for pain-free bladder instillation, enables the treatment of the bladder and the urethra at the same time, which is impossible with a catheter.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | Gastroenterology, Urology | 876.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64249 | Urethral intravesical infusion tip | A small luminal device intended to be fitted onto a syringe (not included) to allow for administration of fluids (e.g., pharmaceuticals) into the bladder (intravesical) via the urethra. It includes a short tip intended to be inserted into the urethra with a flange intended to prevent leakage/backflow during instillation. It is intended for use on both male and female patients as an alternative to urethral instillation via a catheter. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05996617000050 | GS1 | ||||
| Package | 05996617000814 | GS1 | 5pcs/basic box | 5 | In Commercial Distribution | |
| Package | 05996617000821 | GS1 | 10pcs/basic box | 10 | In Commercial Distribution | |
| Package | 05996617000326 | GS1 | 100pcs/basic box | 100 | In Commercial Distribution | |
| Package | 05996617000333 | GS1 | 100basic box/carton | 100 | In Commercial Distribution | |
| Package | 05996617000876 | GS1 | 20basic box/carton | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- +36209451561
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 32 | Millimeter | |
| Device Size Text, specify | Penetration depth: 8mm |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 35 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 35 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 70 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 70 Percent (%) Relative Humidity