PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C
ADAPTA MEDICAL, INC
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008772421 | 3008772421 | ADAPTA MEDICAL, INC. | 1 | N | 2026-01-01 | 142 Talamine Ct Colorado Springs CO US 80907 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00851847007000 | n-Able Cath™ - n-Able Cath Hydro-Straight, Sterile, Single-Use 14 French Intermittent Urinary Catheter. | 855-329-8355 | glen.house@adaptamedical.com |
| 00851847007000 | n-Able Cath™ - n-Able Cath Hydro-Straight, Sterile, Single-Use 14 French Intermittent Urinary Catheter. | 855-329-8355 | brent.janaky@adaptamedical.com |
| 00851847007024 | n-Able Cath™ - n-Able Cath Hydro-Straight, Sterile, Single-Use 14 French Intermittent Urinary Catheter. | 855-329-8355 | brent.janaky@adaptamedical.com |
| 00851847007031 | mPower Cath™ - mPower Cath™ Hydro-Straight Sterile, Single-Use 14 Fr Intermittent Urinary Catheter. | 855-329-8355 | brent.janaky@adaptamedical.com |
| 00851847007031 | mPower Cath™ - mPower Cath™ Hydro-Straight Sterile, Single-Use 14 Fr Intermittent Urinary Catheter. | 855-329-8355 | glen.house@adaptamedical.com |
| 00851847007055 | PerfIC Cath™ - PerfIC Cath™ Hydro-Straight, Sterile, Single-Use 14 French Intermittent Urinary Catheter. | 855-329-8355 | brent.janaky@adaptamedical.com |
| 00851847007055 | PerfIC Cath™ - PerfIC Cath™ Hydro-Straight, Sterile, Single-Use 14 French Intermittent Urinary Catheter. | 855-329-8355 | glen.house@adaptamedical.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 122071 | 2063366980 | K161445 | PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C | EZD | 2016-08-16 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| EZD | 1 | 2016-08-16 |
ADAPTA MEDICAL, INC
ADAPTA MEDICAL, INC
2016-12-28
2016-12-28
2016-12-27
2016-12-28