Other products from "SPINEART SA"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 07640305160226 MPF-IN 04 00-N MPF-IN 04 00-N TROCAR AWL KWP,NKB Appliance, Fixation, Spinal Interlaminal,Thoracolumbosacral Pedicle Screw System 2 PERLA ® TL MIS
2 07640151087623 PAD-IM TI 16-S Posterior Axial Device - Titanium PEK Spinous Process Plate 2 ROMEO 2 PAD POSTERIOR AXIAL DEVICE
3 07640151087609 PAD-IM TI 12-S Posterior Axial Device - Titanium PEK Spinous Process Plate 2 ROMEO 2 PAD POSTERIOR AXIAL DEVICE
4 07640151084073 ELL-CC MU 43-S Cross Connector / Multiaxial MNH,MNI,KWP Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation,Ap Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation,Appliance, Fixation, Spinal Interlaminal 2 ROMEO Posterior Osteosynthesis system
5 07640178975262 CPF-IN 22 02-N CPF-IN 22 02-N Screwdriver Tube KWP Appliance, Fixation, Spinal Interlaminal 2 PERLA ®
6 07640151082970 ELL-DS 07 35-S 25D Screw MNH,MNI,KWP Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation,Ap Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation,Appliance, Fixation, Spinal Interlaminal 2 ROMEO Posterior Osteosynthesis system
7 07640151082949 ELL-DS 06 80-S 25D Screw MNH,MNI,KWP Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation,Ap Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation,Appliance, Fixation, Spinal Interlaminal 2 ROMEO Posterior Osteosynthesis system
8 07640151082925 ELL-DS 06 60-S 25D Screw MNH,MNI,KWP Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation,Ap Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation,Appliance, Fixation, Spinal Interlaminal 2 ROMEO Posterior Osteosynthesis system
9 07640450863447 TRY-IN 51 01-N TRY-IN 51 01-N 3D PRINTED HAN ODP Intervertebral Fusion Device With Bone Graft, Cervical 2 TRYPTIK ® TI
10 07640151082833 ELL-DS 55 45-S 25D Screw MNH,MNI,KWP Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation,Ap Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation,Appliance, Fixation, Spinal Interlaminal 2 ROMEO Posterior Osteosynthesis system
11 07640450860989 TLF-SC 00 00-N TLF-SC 00 00-N SETSCREW KWP,NKB Appliance, Fixation, Spinal Interlaminal,Thoracolumbosacral Pedicle Screw System 2 PERLA ® TL
12 07640151082819 ELL-DS 55 35-S 25D Screw MNH,MNI,KWP Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation,Ap Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation,Appliance, Fixation, Spinal Interlaminal 2 ROMEO Posterior Osteosynthesis system
13 07640151082772 ELL-DS 05 40-S 25D Screw MNH,MNI,KWP Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation,Ap Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation,Appliance, Fixation, Spinal Interlaminal 2 ROMEO Posterior Osteosynthesis system
14 07640151082703 ELL-DS 45 25-S 25D Screw MNH,MNI,KWP Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation,Ap Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation,Appliance, Fixation, Spinal Interlaminal 2 ROMEO Posterior Osteosynthesis system
15 07640151082680 ELL-DS 04 40-S 25D Screw MNH,MNI,KWP Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation,Ap Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation,Appliance, Fixation, Spinal Interlaminal 2 ROMEO Posterior Osteosynthesis system
16 07640151082659 ELL-DS 04 25-S 25D Screw MNH,MNI,KWP Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation,Ap Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation,Appliance, Fixation, Spinal Interlaminal 2 ROMEO Posterior Osteosynthesis system
17 07640151081928 ELL-RD 13 50-S Rod Cobalt Chromium / Straight KWP,MNH,MNI Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixa Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation 2 ROMEO Posterior Osteosynthesis system
18 07640305160899 MPF-PX 65 30-S MPF-PX 65 30-S XTAB CANNULATED POLYAXIAL SCREW KWP,NKB Appliance, Fixation, Spinal Interlaminal,Thoracolumbosacral Pedicle Screw System 2 PERLA ® TL MIS
19 07640178975200 CPF-IN 17 00-N CPF-IN 17 00-N Pusher KWP Appliance, Fixation, Spinal Interlaminal 2 PERLA ®
20 07640185341722 SPE-US 00 40-N SPE-US 00 40-N ANGLED TAP HWX Tap, Bone 1 SCARLET AC-T
21 07640178984981 MIS-IN 52 10-N Trocar Handle HWJ Awl 1 ROMEO 2 MIS
22 07640178985704 SPE-US 00 28-N SPE-US 00 28-N ROD HOLDER NKG,KWP Orthosis, Cervical Pedicle Screw Spinal Fixation,Appliance, Fixation, Spinal Interlaminal 2 PERLA ®
23 07640178981584 JUT-IN 03 12-N JUT-IN 03 12-N TRIAL IMPLANT Ti TL HWT Template 1 JULIET ® INSTRUMENTATION
24 07640178980662 JUL-LT 6S 8C-S JUL-LT 6S 8C-S JUL-LT 6S 8C-S MAX Intervertebral Fusion Device With Bone Graft, Lumbar 2 JULIET ® LL
25 07640178975934 CPF-SS 04 22-S CPF-SS 04 22-S NKG,KWP Orthosis, Cervical Pedicle Screw Spinal Fixation,Appliance, Fixation, Spinal Interlaminal 2 PERLA ®
26 07640151081225 TRY-AC 12 09-S Cervical Cage / Convex ODP Intervertebral Fusion Device With Bone Graft, Cervical 2 TRYPTIK Anterior Intersomatic Cervical cage
27 07640151081010 TRY-CL 14 12-S Cervical Cage / Lordotic ODP Intervertebral Fusion Device With Bone Graft, Cervical 2 TRYPTIK Anterior Intersomatic Cervical cage
28 07640178971301 ELL-R6 15 50-S Rod Cobalt Chromium / Prebent MNI,MNH Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation 2 ROMEO Posterior Osteosynthesis system
29 07640151080969 TRY-CL 14 07-S Cervical Cage / Lordotic ODP Intervertebral Fusion Device With Bone Graft, Cervical 2 TRYPTIK Anterior Intersomatic Cervical cage
30 07640151080952 TRY-CL 14 06-S Cervical Cage / Lordotic ODP Intervertebral Fusion Device With Bone Graft, Cervical 2 TRYPTIK Anterior Intersomatic Cervical cage
31 07640151080945 TRY-CL 14 05-S Cervical Cage / Lordotic ODP Intervertebral Fusion Device With Bone Graft, Cervical 2 TRYPTIK Anterior Intersomatic Cervical cage
32 07640151112578 JLL-IN 06 08-N JLL-IN 06 08-N PADDLE SHAVER 8 LWK Razor, Surgical 1 JULIET ® INSTRUMENTATION
33 07640151096304 CPF-CS 04 52-S CC PREFERRED ANGLE SCREW NKG,KWP Orthosis, Cervical Pedicle Screw Spinal Fixation,Appliance, Fixation, Spinal Interlaminal 2 PERLA ®
34 07640151095239 CPF-IN 20 00-N CPF-IN 20 00-N Rocker KWP Appliance, Fixation, Spinal Interlaminal 2 PERLA ®
35 07640151092597 JUL-IN 19 10-N JUL-IN 19 10-N Paddle Shaver H10 MAX Intervertebral Fusion Device With Bone Graft, Lumbar 2 JULIET INSTRUMENTATION
36 07640139346179 ELL-RD 10 30-S KWP,MNH,MNI Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixa Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation 2 ROMEO Posterior Osteosynthesis System
37 07640139345455 ELL-PS 45 45-S Polyaxial Screw KWP,MNH,MNI Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixa Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation 2 ROMEO Posterior Osteosynthesis System
38 07640139345448 ELL-PS 45 40-S Polyaxial Screw KWP,MNH,MNI Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixa Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation 2 ROMEO Posterior Osteosynthesis System
39 07640151089474 OTO-BC 09 02-N OTO-BC 09 02-N RETRACTOR BLADE GAD Retractor 1 OTELO INSTRUMENTATION
40 07640151087579 ELL-IN 05 06-N ELL-IN 05 06-N K-WIRE BLUNT - NITINOLFINAL TIGHTENER KWP,MNH,MNI Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixa Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation 2 ROMEO 2 INSTRUMENTATION
41 07640139345424 ELL-PS 45 30-S Polyaxial Screw KWP,MNH,MNI Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixa Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation 2 ROMEO Posterior Osteosynthesis System
42 07640151083021 ELL-DS 07 55-S 25D Screw MNH,MNI,KWP Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation,Ap Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation,Appliance, Fixation, Spinal Interlaminal 2 ROMEO Posterior Osteosynthesis system
43 07640151080846 ELL-IN 01 34-N ELL-IN 01 34-N REDUCER T-HANDLE HWN,MNI,MNH Instrument, Compression,Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolist Instrument, Compression,Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation 1 ROMEO 2 INSTRUMENTATION
44 07640139347329 ELL-RD 30 30-S Rod Straight KWP,MNH,MNI Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixa Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation 2 ROMEO Posterior Osteosynthesis System
45 07640139346193 ELL-RD 10 50-S Rod Cobalt Chromium / Prebent KWP,MNH,MNI Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixa Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation 2 ROMEO Posterior Osteosynthesis System
46 07640139347404 ELL-RD 30 90-S Rod Straight KWP,MNH,MNI Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixa Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation 2 ROMEO Posterior Osteosynthesis System
47 07640139347213 ELL-PS 06 90-S Polyaxial Screw KWP,MNH,MNI Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixa Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation 2 ROMEO Posterior Osteosynthesis System
48 07640139345769 ELL-PS 07 80-S Polyaxial Screw KWP,MNH,MNI Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixa Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation 2 ROMEO Posterior Osteosynthesis System
49 07640139343970 ELL-MS 45 25-S Monoaxial Screw KWP,MNH,MNI Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixa Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation 2 ROMEO Posterior Osteosynthesis system
50 07640139340061 MOS-CA 14 07-S Cervical Cage ODP Intervertebral Fusion Device With Bone Graft, Cervical 2 TRYPTIK CA ANTERIOR INTERSOMATIC CERVICAL CAGE
Other products with the same Product Codes "KWP, MNH, MNI"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 08057432565746 ACP-04T526 ACP SINTEA PLUSTEK SRL
2 08057432565739 ACP-04T525 ACP SINTEA PLUSTEK SRL
3 08057432565678 PLS-49T5300 PLS SINTEA PLUSTEK SRL
4 08057432565661 PLS-49T5200 PLS SINTEA PLUSTEK SRL
5 08057432565654 PLS-49T5140 PLS SINTEA PLUSTEK SRL
6 08057432565647 PLS-49T5130 PLS SINTEA PLUSTEK SRL
7 08057432565630 PLS-48T5140 PLS SINTEA PLUSTEK SRL
8 08057432565623 PLS-48T5130 PLS SINTEA PLUSTEK SRL
9 08057432565616 PLS-48T5090 PLS SINTEA PLUSTEK SRL
10 08057432565609 PLS-48T5085 PLS SINTEA PLUSTEK SRL
11 08057432565593 PLS-48T5080 PLS SINTEA PLUSTEK SRL
12 08057432565586 PLS-48T5075 PLS SINTEA PLUSTEK SRL
13 08057432565579 PLS-48T5070 PLS SINTEA PLUSTEK SRL
14 08057432565562 PLS-48T5065 PLS SINTEA PLUSTEK SRL
15 08057432565555 PLS-48T5060 PLS SINTEA PLUSTEK SRL
16 08057432565548 PLS-48T5055 PLS SINTEA PLUSTEK SRL
17 08057432565531 PLS-48T5050 PLS SINTEA PLUSTEK SRL
18 08057432565524 PLS-48T5045 PLS SINTEA PLUSTEK SRL
19 08057432565517 PLS-48T5040 PLS SINTEA PLUSTEK SRL
20 08057432565500 PLS-48T5035 PLS SINTEA PLUSTEK SRL
21 08057432565494 PLS-48T5030 PLS SINTEA PLUSTEK SRL
22 08057432565487  PLS-48CC8 PLS SINTEA PLUSTEK SRL
23 08057432565470  PLS-48CC6 PLS SINTEA PLUSTEK SRL
24 08057432565463  PLS-48CC5 PLS SINTEA PLUSTEK SRL
25 08057432565456  PLS-48CC4 PLS SINTEA PLUSTEK SRL
26 08057432565449  PLS-48CC3 PLS SINTEA PLUSTEK SRL
27 08057432565432  PLS-48CC2 PLS SINTEA PLUSTEK SRL
28 08057432565425  PLS-48CC1 PLS SINTEA PLUSTEK SRL
29 08057432565418  PLS-47CC4 PLS SINTEA PLUSTEK SRL
30 08057432565401  PLS-47CC3 PLS SINTEA PLUSTEK SRL
31 08057432565395  PLS-47CC2 PLS SINTEA PLUSTEK SRL
32 08057432565388 PLS-760T58 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# PLS SINTEA PLUSTEK SRL
33 08057432565371 PLS-760T57 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# PLS SINTEA PLUSTEK SRL
34 08057432565364 PLS-760T56 PLS SINTEA PLUSTEK SRL
35 08057432565357 PLS-760T55 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# PLS SINTEA PLUSTEK SRL
36 08057432565340 PLS-760T540 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# PLS SINTEA PLUSTEK SRL
37 08057432565333 PLS-755T540 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# PLS SINTEA PLUSTEK SRL
38 08057432565326 PLS-660T58 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# PLS SINTEA PLUSTEK SRL
39 08057432565319 PLS-655T58 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# PLS SINTEA PLUSTEK SRL
40 08057432565302 PLS-650T58 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# PLS SINTEA PLUSTEK SRL
41 08057432565296 PLS-645T58 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# PLS SINTEA PLUSTEK SRL
42 08057432565289 PLS-640T58 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# PLS SINTEA PLUSTEK SRL
43 08057432565272 PLS-635T58 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# PLS SINTEA PLUSTEK SRL
44 08057432565265 PLS-630T58 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# PLS SINTEA PLUSTEK SRL
45 08057432565258 PLS-6100T58 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# PLS SINTEA PLUSTEK SRL
46 08057432565241 PLS-6095T58 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# PLS SINTEA PLUSTEK SRL
47 08057432565234 PLS-6090T58 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# PLS SINTEA PLUSTEK SRL
48 08057432565227 PLS-6085T58 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# PLS SINTEA PLUSTEK SRL
49 08057432565210 PLS-6080T58 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# PLS SINTEA PLUSTEK SRL
50 08057432565203 PLS-6075T58 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# PLS SINTEA PLUSTEK SRL