The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures. The device is indicated for visualizing posterior ocular structures including, but not limited to, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, optic nerve head, vitreous and choroid. The PLEX Elite SS-OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.

Detalles del retiro

Fabricante

Carl Zeiss Meditec, Inc.

Distribuidor

Worldwide distribution - US Nationwide distribution in the states of CA, TX, NY, MA, OH, PA, IA, , KY, FL, MI, IL, MD and Germany, Japan, Switzerland, France Italy, Australia, Austria, Korea, China, India, Canada, Singapore, Norway, Taiwan, Israel, UAE.

Lote

OBO /HJO Serial Numbers: PE9000-001, PE9000-002, PE9000-003, PE9000-003,PE9000-004, PE9000-005, PE9000-006, PE9000-007, PE9000-008, PE9000-009, PE9000-0010, PE9000-0011, PE9000-0012, PE9000-0013, PE9000-0014, PE9000-0015, PE9000-0016, PE9000-0020, PE9000-0021, PE9000-0022, PE9000-0023, PE9000-0024, PE9000-0025, PE9000-0026, PE9000-0027, PE9000-0029, PE9000-0030, PE9000-0031, PE9000-0032, PE9000-0033, PE9000-0034, PE9000-0035, PE9000-0036, PE9000-0038, PE9000-0039, PE9000-0040, PE9000-0041, PE9000-0042, PE9000-0043, PE9000-0044, PE9000-0045, PE9000-0046, PE9000-0047, PE9000-0048, PE9000-0049, PE9000-0050, PE9000-0051, PE9000-0052, PE9000-0053, PE9000-0054, PE9000-0055, PE9000-0056, PE9000-0057, PE9000-0058, PE9000-0059, PE9000-0060, PE9000-0061, PE9000-0062, PE9000-0063, PE9000-0064, PE9000-0065, PE9000-0066, PE9000-0067, PE9000-0068, PE9000-0069, PE9000-0070, PE9000-0071, PE9000-0072, PE9000-0073, PE9000-0074, PE9000-0075, PE9000-0076, PE9000-0077, PE9000-0078, PE9000-0079, PE9000-0080, PE9000-0081, PE9000-0082, PE9000-0083, PE9000-0084, PE9000-0085, PE9000-0086, PE9000-0087, PE9000-0088, PE9000-0089, PE9000-0090, PE9000-0091, PE9000-0092, PE9000-0093, PE9000-0094, PE9000-0095, PE9000-0096, PE9000-0097, PE9000-0098, PE9000-0099, PE9000-0100, PE9000-0101, PE9000-0102, PE9000-0103, PE9000-0104, PE9000-0105, PE9000-0106, PE9000-0107, PE9000-0108, PE9000-0109, PE9000-0110, PE9000-0111, PE9000-0112, PE9000-0113, PE9000-0114, PE9000-0115, PE9000-0116, PE9000-0117, PE9000-0118, PE9000-0119, PE9000-0120, PE9000-0121, PE9000-0122, PE9000-0123, PE9000-0124, PE9000-0125, PE9000-0126, PE9000-0127, PE9000-0128, PE9000-0129, PE9000-0130, PE9000-0131, PE9000-0132, PE9000-0133, PE9000-0134, PE9000-0135, PE9000-0137, PE9000-0138, PE9000-0139, PE9000-0140, PE9000-0141, PE9000-0142, PE9000-0143, PE9000-0144, PE9000-0145, PE9000-0146, PE9000-0147, PE9000-0148, PE9000-0149, PE9000-0150, PE9000-0151, PE9000-0152, PE9000-0153, PE9000-0154, PE9000-0155, PE9000-0156, PE9000-0158

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States