| Device |
apparatus, suction, operating-room, wall vacuum powered (export only) |
| Definition |
Intended to be used for the removal of prosthetic breast implant specimens. |
| Physical State |
The device is a sterile, transparent, rigid bi-conical device that, when assembled, will attach to an external vacuum source and provide suction in order to remove prosthetic breast implants. This is a single use device available by prescription only, for professional use in a clinical setting. The two cones (top and bottom) are made of molded thermoplastic and seal together with a silicone O-ring. |
| Technical Method |
The device is intended to be used for the removal of prosthetic breast implant specimens, including intact and ruptured silicone gel implants as well as intact saline implants. |
| Target Area |
Breast |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | QOJ |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Plastic and Reconstructive Surgery Devices
(DHT4B)
|
|
Not Classified Reason
|
For Export Only
|
|---|
| Submission Type |
Contact ODE
|
|---|
| Device Class |
Not Classified
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
