| Z-0029-2020 |
CooperSurgical, Inc. |
2
|
Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated to be flush fitted within workstations. Intended use: Provide a favorable temperature environment for the embryo during the IVF procedure. |
| Z-0006-2019 |
N/A |
3
|
ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF:
BA22-120/I20-40,
BA22-100/I20-40,
BA22-80/I20-40,
BA22-60/I20-40,
BA22-40/I20-40,
BA22-120/I16-40,
BA22-100/I16-40,
BA22-80/I16-40,
BA22-60/I16-40,
BA22-40/I16-40,
BA22-120/I13-40,
BA22-100/I13-40,
BA22-80/I13-40,
BA22-60/I13-40,
BA22-40/I13-40,
BA22-110/I20-30,
BA22-90/I20-30,
BA22-70/I20-30,
BA22-50/I20-30,
BA22-110/I16-30,
BA22-90/I16-30,
BA22-70/I16-30,
BA22-50/I16-30,
BA22-100/I20-55,
BA22-80/I20-55,
BA22-100/I16-55,
BA22-80/I16-55,
BA25-120/I20-40,
BA25-100/I20-40,
BA25-80/I20-40,
BA25-60/I20-40,
BA25-40/I20-40,
BA25-120/I16-40,
BA25-100/I16-40,
BA25-80/I16-40,
BA25-60/I16-40,
BA25-40/I16-40,
BA25-120/I13-40,
BA25-100/I13-40,
BA25-80/I13-40,
BA25-60/I13-40,
BA25-40/I13-40,
BA25-110/I20-30,
BA25-90/I20-30,
BA25-70/I20-30,
BA25-50/I20-30,
BA25-110/I16-30,
BA25-90/I16-30,
BA25-70/I16-30,
BA25-50/I16-30,
BA25-100/I20-55,
BA25-80/I20-55,
BA25-100/I16-55,
BA25-80/I16-55,
BA28-120/I20-40,
BA28-100/I20-40,
BA28-80/I20-40,
BA28-60/I20-40,
BA28-40/I20-40,
BA28-120/I16-40,
BA28-100/I16-40,
BA28-80/I16-40,
BA28-60/I16-40,
BA28-40/I16-40,
BA28-120/I13-40,
BA28-100/I13-40,
BA28-80/I13-40,
BA28-60/I13-40,
BA28-40/I13-40,
BA28-110/I20-30,
BA28-90/I20-30,
BA28-70/I20-30,
BA28-50/I20-30,
BA28-110/I16-30,
BA28-90/I16-30,
BA28-70/I16-30,
BA28-50/I16-30,
BA28-100/I20-55,
BA28-80/I20-55,
BA28-100/I16-55,
BA28-80/I16-55 |
| Z-0007-2019 |
N/A |
3
|
ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF:
BEA22-120/I20-40,
BEA22-100/I20-40,
BEA22-80/I20-40,
BEA22-60/I20-40,
BEA22-40/I20-40,
BEA22-120/I16-40,
BEA22-100/I16-40,
BEA22-80/I16-40,
BEA22-60/I16-40,
BEA22-40/I16-40,
BEA22-120/I13-40,
BEA22-100/I13-40,
BEA22-80/I13-40,
BEA22-60/I13-40,
BEA22-40/I13-40,
BEA22-110/I20-30,
BEA22-90/I20-30,
BEA22-70/I20-30,
BEA22-50/I20-30,
BEA22-110/I16-30,
BEA22-90/I16-30,
BEA22-70/I16-30,
BEA22-50/I16-30,
BEA22-100/I20-55,
BEA22-80/I20-55,
BEA22-100/I16-55,
BEA22-80/I16-55,
BEA25-120/I20-40,
BEA25-100/I20-40,
BEA25-80/I20-40,
BEA25-60/I20-40,
BEA25-40/I20-40,
BEA25-120/I16-40,
BEA25-100/I16-40,
BEA25-80/I16-40,
BEA25-60/I16-40,
BEA25-40/I16-40,
BEA25-120/I13-40,
BEA25-100/I13-40,
BEA25-80/I13-40,
BEA25-60/I13-40,
BEA25-40/I13-40,
BEA25-110/I20-30,
BEA25-90/I20-30,
BEA25-70/I20-30,
BEA25-50/I20-30,
BEA25-110/I16-30,
BEA25-90/I16-30,
BEA25-70/I16-30,
BEA25-50/I16-30,
BEA25-100/I20-55,
BEA25-80/I20-55,
BEA25-100/I16-55,
BEA25-80/I16-55,
BEA28-120/I20-40,
BEA28-100/I20-40,
BEA28-80/I20-40,
BEA28-60/I20-40,
BEA28-40/I20-40,
BEA28-120/I16-40,
BEA28-100/I16-40,
BEA28-80/I16-40,
BEA28-60/I16-40,
BEA28-40/I16-40,
BEA28-120/I13-40,
BEA28-100/I13-40,
BEA28-80/I13-40,
BEA28-60/I13-40,
BEA28-40/I13-40,
BEA28-110/I20-30,
BEA28-90/I20-30,
BEA28-70/I20-30,
BEA28-50/I20-30,
BEA28-110/I16-30,
BEA28-90/I16-30,
BEA28-70/I16-30,
BEA28-50/I16-30,
BEA28-100/I20-55,
BEA28-80/I20-55,
BEA28-100/I16-55,
BEA28-80/I16-55 |
| Z-0008-2019 |
N/A |
3
|
ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO,
AFX Proximal Accessory,
Infrarenal Model #/REF:
A22-22/C55,
A22-22/C75,
A22-22/C95,
A25-25/C55,
A25-25/C75,
A25-25/C95,
A28-28/C55,
A28-28/C75,
A28-28/C95,
A31-31/C80,
A31-31/C100,
A34-34/C80,
A34-34/C100;
Suprarenal Model #/REF:
A22-22/C55-O20,
A22-22/C75-O20,
A22-22/C95-O20,
A25-25/C55-O20,
A25-25/C75-O20,
A25-25/C95-O20,
A28-28/C55-O20,
A28-28/C75-O20,
A28-28/C95-O20,
A31-31/C80-O20,
A31-31/C100-O20,
A34-34/C80-O20,
A34-34/C100-O20;
AFX Vela,
Infrarenal Model #/REF:
A22-22/C55V,
A22-22/C75V,
A22-22/C95V,
A25-25/C55V,
A25-25/C75V,
A25-25/C95V,
A28-28/C55V,
A28-28/C75V,
A28-28/C95V,
A31-31/C80V,
A31-31/C100V,
A34-34/C80V,
A34-34/C100V;
Suprarenal Model #/REF:
A22-22/C55-O20V,
A22-22/C75-O20V,
A22-22/C95-O20V,
A25-25/C55-O20V,
A25-25/C75-O20V,
A25-25/C95-O20V,
A28-28/C55-O20V,
A28-28/C75-O20V,
A28-28/C95-O20V,
A31-31/C80-O20V,
A31-31/C100-O20V,
A34-34/C80-O20V,
A34-34/C100-O20V |
| Z-0009-2019 |
N/A |
3
|
ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Accessory Model #/REF:
I16-16/C55,
I16-16/C55F,
I16-16/C88,
I20-13/C70F,
I20-13/C88F,
I16-16/C55,
I16-16/C55F,
I16-16/C88,
I20-13/C70F,
I20-13/C88F;
AFX Stand Alone
I16-16/C55 SA,
I16-16/C55F SA,
I16-16/C88 SA,
I20-13/C70F SA,
I20-13/C88F SA,
I20-20/C55 SA,
I20-20/C55F SA,
IS20-25/C55 SA,
IF20-25/C65 SA,
IS20-25/C65 SA |