| Primary Device ID | 05996617000050 |
| NIH Device Record Key | a6077507-22df-4d48-a8ca-6c995cbec24b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UroDapter®/MID-II |
| Version Model Number | 17001 |
| Company DUNS | 860789069 |
| Company Name | PHARMICO MEDICAL Korlátolt Felelősségű Társaság |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | +36209451561 |
| jeno.kunovits@urosystem.com | |
| Phone | +36209451561 |
| jeno.kunovits@urosystem.com | |
| Phone | +36209451561 |
| jeno.kunovits@urosystem.com | |
| Phone | +36209451561 |
| jeno.kunovits@urosystem.com | |
| Phone | +36209451561 |
| jeno.kunovits@urosystem.com | |
| Phone | +36209451561 |
| jeno.kunovits@urosystem.com | |
| Phone | +36209451561 |
| jeno.kunovits@urosystem.com | |
| Phone | +36209451561 |
| jeno.kunovits@urosystem.com | |
| Phone | +36209451561 |
| jeno.kunovits@urosystem.com | |
| Phone | +36209451561 |
| jeno.kunovits@urosystem.com | |
| Phone | +36209451561 |
| jeno.kunovits@urosystem.com | |
| Phone | +36209451561 |
| jeno.kunovits@urosystem.com |
| Length | 32 Millimeter |
| Device Size Text, specify | 0 |
| Length | 32 Millimeter |
| Device Size Text, specify | 0 |
| Length | 32 Millimeter |
| Device Size Text, specify | 0 |
| Length | 32 Millimeter |
| Device Size Text, specify | 0 |
| Length | 32 Millimeter |
| Device Size Text, specify | 0 |
| Length | 32 Millimeter |
| Device Size Text, specify | 0 |
| Length | 32 Millimeter |
| Device Size Text, specify | 0 |
| Length | 32 Millimeter |
| Device Size Text, specify | 0 |
| Length | 32 Millimeter |
| Device Size Text, specify | 0 |
| Length | 32 Millimeter |
| Device Size Text, specify | 0 |
| Length | 32 Millimeter |
| Device Size Text, specify | 0 |
| Length | 32 Millimeter |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05996617000050 [Primary] |
| GS1 | 05996617000326 [Package] Package: 100pcs/basic box [100 Units] In Commercial Distribution |
| GS1 | 05996617000333 [Package] Contains: 05996617000821 Package: 100basic box/carton [100 Units] In Commercial Distribution |
| GS1 | 05996617000814 [Package] Package: 5pcs/basic box [5 Units] In Commercial Distribution |
| GS1 | 05996617000821 [Package] Package: 10pcs/basic box [10 Units] In Commercial Distribution |
| GS1 | 05996617000876 [Package] Contains: 05996617000326 Package: 20basic box/carton [20 Units] In Commercial Distribution |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-02 |
| Device Publish Date | 2025-08-25 |