Definition: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.Fda.Gov/cdrh/ode/convkit.Html. This Kit, As Described In The Guidance Above, Is Under Enforcemen
| Device Type ID | 190 |
| Device Name | Nerve Block Tray |
| Physical State | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Kit, As Described In The Guidance Above, Is Under Enforcemen |
| Technical Method | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Kit, As Described In The Guidance Above, Is Under Enforcemen |
| Target Area | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Kit, As Described In The Guidance Above, Is Under Enforcemen |
| Regulation Description | Anesthesia Conduction Kit. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Anesthesiology Devices Branch (ANDB) |
| Submission Type | Enforcement Discretion |
| CFR Regulation Number | 868.5140 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OGJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 190 |
| Device | Nerve Block Tray |
| Product Code | OGJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Anesthesia Conduction Kit. |
| CFR Regulation Number | 868.5140 [🔎] |
| Device Problems | |
|---|---|
Difficult To Remove | 9 |
Material Separation | 5 |
Kinked | 4 |
Difficult To Advance | 3 |
Break | 3 |
Fluid Leak | 3 |
Torn Material | 3 |
Material Fragmentation | 3 |
Physical Resistance | 3 |
Contamination / Decontamination Problem | 3 |
Unraveled Material | 2 |
Device Contaminated During Manufacture Or Shipping | 2 |
Leak / Splash | 1 |
Hole In Material | 1 |
Cut In Material | 1 |
Detachment Of Device Or Device Component | 1 |
Crack | 1 |
Uncoiled | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Material Integrity Problem | 1 |
| Total Device Problems | 51 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Centurion Medical Products Corporation | II | Jan-08-2015 |