Acera is Committed to Setting the Standard for Quality and Compliance
Our Quality Policy: Acera Surgical is committed to patient safety and will provide high quality medical devices, while meeting or exceeding all regulatory requirements and customer expectations, by thoughtfully monitoring the effectiveness of the quality system, and continually improving product and process performance.
Setting the highest standards in the market for ethics and the way our company behaves is extremely important.
- Jake Wilson, CEO Emeritus & Board Member of Acera Surgical
Acera’s Quality System was established based upon the requirements of the following regulations and standards:
- United States Food and Drug Administration (FDA), Quality System Regulation, 21 CFR Part 820 and its referenced parts
- ISO 14971:2019, Medical Devices – Application of risk management to medical devices
- ISO 13485:2016, Medical Devices – Quality management systems - Requirements for regulatory purposes
Restrata Sheet eIFU
| |
|
|
eIFU |
|
| Item # |
Size & Configuration |
Coverage (cm2) |
Wound Management |
Soft Tissue Reinforcement |
| RWM1-0.5X1 |
1.3 x 2.5 cm sheet |
3.25 |
For a downloadable version
of the IFU, please click here:
MKG-20002-15
|
For a downloadable version
of the IFU, please click here:
MKG-20005-05
|
| RWM1-1X1 |
2.5 x 2.5 cm sheet |
6.25 |
| RWM1-1X2 |
2.5 x 5 cm sheet |
12.5 |
| RWM1-1.5X2 |
3.8 x 5 cm sheet |
18.5 |
| RWM1-1X3 |
2.5 x 7.5 cm sheet |
18.75 |
| RWM1-2X2 |
5 x 5 cm sheet |
25 |
| RWM1-3X3 |
7.5 x 7.5 cm sheet |
56.25 |
| RWM1-4X5 |
10 x 12.5 cm sheet |
125 |
| RWM1-5X7 |
12.5 x 17.5 cm sheet |
225 |
Restrata Mesh eIFU
| |
|
|
eIFU |
|
| Item # |
Size & Configuration |
Coverage (cm2) |
Wound Management |
Soft Tissue Reinforcement |
| RMESH-1.5x2 |
3.8 x 5 cm meshed |
19 up to 38 |
For a downloadable version
of the IFU, please click here:
MKG-20002-15
|
For a downloadable version
of the IFU, please click here:
MKG-20005-05
|
| RMESH-2x2 |
5 x 5 cm meshed |
25 up to 50 |
| RMESH-3x3 |
7.5 x 7.5 cm meshed |
56 up to 112 |
| RMESH-4x5 |
10 x 12.5 cm meshed |
125 up to 250 |
| RMESH-5x7 |
12.5 x 17.5 cm meshed |
225 up to 450 |
Restrata MiniMatrix eIFU
| |
|
|
eIFU |
|
| Item # |
Size & Configuration |
Coverage (cm2) |
Wound Management |
|
| RMINI-100 |
100 mg micronized |
10 up to 20 |
For a downloadable version
of the IFU, please click here:
MKG-20007-03
|
|
| RMINI-250 |
250 mg micronized |
25 up to 50 |
| RMINI-500 |
500 mg micronized |
50 up to 100 |
| RMINI-1000 |
1,000 mg micronized |
100 up to 200 |
| RMINI-2000 |
2,000 mg micronized |
200 up to 400 |