| Device Type ID | 2858 |
| Device Name | Container, Frozen Donor Tissue Storage |
| Review Panel | General Hospital |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | LPZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2858 |
| Device | Container, Frozen Donor Tissue Storage |
| Product Code | LPZ |
| Device Problems | |
|---|---|
Fracture | 43 |
Material Integrity Problem | 31 |
Break | 31 |
Device Issue | 24 |
Leak / Splash | 15 |
Crack | 10 |
Fluid Leak | 7 |
Physical Property Issue | 6 |
Material Perforation | 4 |
Torn Material | 3 |
Hole In Material | 3 |
Device Handling Problem | 2 |
Use Of Device Problem | 2 |
Misconnection | 2 |
Material Puncture / Hole | 1 |
Incomplete Or Missing Packaging | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Material Deformation | 1 |
Defective Device | 1 |
Stretched | 1 |
Disconnection | 1 |
Device Markings / Labelling Problem | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Material Distortion | 1 |
| Total Device Problems | 193 |