No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00191083017198 | 724-918 | 724-918 | STRMLN TL, LONG HANDLE SCREW INSERTER | HWR | DRIVER, PROSTHESIS | 1 | Streamline TL Spinal Fixation System |
2 | 00191083017181 | 724-874 | 724-874 | STREAMLINE TL STAB AND GRAB FINAL DRIVER | HXX | SCREWDRIVER | 1 | Streamline TL Spinal Fixation System |
3 | 00191083017174 | 724-863 | 724-863 | STRMLN TL, 02-S-FINDER-T,ADD. ETCH LINES | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Streamline TL Spinal Fixation System |
4 | 00191083017167 | 724-861 | 724-861 | STRMLN TL,NO ROTATE SLEEVE SCRW INSERTER | HWR | DRIVER, PROSTHESIS | 1 | Streamline TL Spinal Fixation System |
5 | 00191083017150 | 724-630 | 724-630 | STREAMLINE TL, FORCEP ROD ROCKER | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Streamline TL Spinal Fixation System |
6 | 00191083017143 | 724-622 | 724-622 | STRMLN TL 8.5mm HUDSON TAP | HWX | TAP, BONE | 1 | Streamline TL Spinal Fixation System |
7 | 00191083017136 | 724-621 | 724-621 | STRMLN TL 7.5mm HUDSON TAP | HWX | TAP, BONE | 1 | Streamline TL Spinal Fixation System |
8 | 00191083017129 | 724-620 | 724-620 | STRMLN TL 6.5mm HUDSON TAP | HWX | TAP, BONE | 1 | Streamline TL Spinal Fixation System |
9 | 00191083017112 | 724-619 | 724-619 | STRMLN TL 5.5mm HUDSON TAP | HWX | TAP, BONE | 1 | Streamline TL Spinal Fixation System |
10 | 00191083017105 | 724-618 | 724-618 | STRMLN TL 4.5mm HUDSON TAP | HWX | TAP, BONE | 1 | Streamline TL Spinal Fixation System |
11 | 00191083017099 | 724-589 | 724-589 | STREAMLINE TL, 3.5mm TAPERED TIP TAP | HWX | TAP, BONE | 1 | Streamline TL Spinal Fixation System |
12 | 00191083017082 | 724-538 | 724-538 | STRMLN TL FIXED WING TIP INSERTER | HWR | DRIVER, PROSTHESIS | 1 | Streamline TL Spinal Fixation System |
13 | 00191083017075 | 724-444 | 724-444 | STRMLN TL YOKE CAPTURE RS SETSCREW INRTR | HWR | DRIVER, PROSTHESIS | 1 | Streamline TL Spinal Fixation System |
14 | 00191083017068 | 724-440 | 724-440 | STRMLN TL, FIXED HANDLED SCREW INSERTER | HWR | DRIVER, PROSTHESIS | 1 | Streamline TL Spinal Fixation System |
15 | 00191083017051 | 724-439 | 724-439 | STRMLN TL, 7.5mm FIXED HANDLED TAP | HWX | TAP, BONE | 1 | Streamline TL Spinal Fixation System |
16 | 00191083017044 | 724-438 | 724-438 | STRMLN TL, 6.5mm FIXED HANDLED TAP | HWX | TAP, BONE | 1 | Streamline TL Spinal Fixation System |
17 | 00191083017037 | 724-437 | 724-437 | STRMLN TL, 5.5mm FIXED HANDLED TAP | HWX | TAP, BONE | 1 | Streamline TL Spinal Fixation System |
18 | 00191083017020 | 724-436 | 724-436 | STRMLN TL, 4.5mm FIXED HANDLED TAP | HWX | TAP, BONE | 1 | Streamline TL Spinal Fixation System |
19 | 00191083017013 | 724-387 | 724-387 | STRMLN TL HUDSON CLEANABLE INSERTER | HWR | DRIVER, PROSTHESIS | 1 | Streamline TL Spinal Fixation System |
20 | 00191083017006 | 724-379 | 724-379 | STRMLN TL, 02-C-FINDER-T, PALM HNDL, NC | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Streamline TL Spinal Fixation System |
21 | 00191083016993 | 724-378 | 724-378 | STRMLN TL, 02-C-FINDER-L, PALM HNDL, NC | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Streamline TL Spinal Fixation System |
22 | 00191083016986 | 724-377 | 724-377 | STRMLN TL, 02-S-FINDER-T, PALM HNDL, NC | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Streamline TL Spinal Fixation System |
23 | 00191083016979 | 724-376 | 724-376 | STRMLN TL, 02-S-FINDER-L, PALM HNDL, NC | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Streamline TL Spinal Fixation System |
24 | 00191083016962 | 724-300 | 724-300 | STRMLN TL STNDRD EASY RELEASE INSERTER | HWR | DRIVER, PROSTHESIS | 1 | Streamline TL Spinal Fixation System |
25 | 00191083016955 | 724-299 | 724-299 | STRMLN TL SHORT EASY RELEASE INSERTER | HWR | DRIVER, PROSTHESIS | 1 | Streamline TL Spinal Fixation System |
26 | 00191083016948 | 724-298 | 724-298 | STREAMLINE TL, 7.0mm TAPERED TIP TAP | HWX | TAP, BONE | 1 | Streamline TL Spinal Fixation System |
27 | 00191083016931 | 724-252 | 724-252 | STRMLN TL 1/4 SQ SET SCREW INSERTER | HWR | DRIVER, PROSTHESIS | 1 | Streamline TL Spinal Fixation System |
28 | 00191083016924 | 724-246 | 724-246 | STRMLN TL,FIXED T-HANDLE SET SCRW INSRTR | HWR | DRIVER, PROSTHESIS | 1 | Streamline TL Spinal Fixation System |
29 | 00191083016917 | 724-244 | 724-244 | STRMLN TL, CANNULATED SCREW INSERTER | HWR | DRIVER, PROSTHESIS | 1 | Streamline TL Spinal Fixation System |
30 | 00191083016900 | 724-240 | 724-240 | STRMLN TL, 5.5mm CANNULATED 8.5" TAP, UL | HWX | TAP, BONE | 1 | Streamline TL Spinal Fixation System |
31 | 00191083016894 | 724-239 | 724-239 | STRMLN TL, 4.5mm CANNULATED 8.5" TAP, UL | HWX | TAP, BONE | 1 | Streamline TL Spinal Fixation System |
32 | 00191083016887 | 724-211 | 724-211 | STREAMLINE TL SHORT TAP SLEEVE | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Streamline TL Spinal Fixation System |
33 | 00191083016870 | 724-210 | 724-210 | STREAMLINE TL 8.5mm SHORT TAP | HWX | TAP, BONE | 1 | Streamline TL Spinal Fixation System |
34 | 00191083016863 | 724-209 | 724-209 | STREAMLINE TL 7.5mm SHORT TAP | HWX | TAP, BONE | 1 | Streamline TL Spinal Fixation System |
35 | 00191083016856 | 724-208 | 724-208 | STREAMLINE TL 6.5mm SHORT TAP | HWX | TAP, BONE | 1 | Streamline TL Spinal Fixation System |
36 | 00191083016849 | 724-207 | 724-207 | STREAMLINE TL 5.5mm SHORT TAP | HWX | TAP, BONE | 1 | Streamline TL Spinal Fixation System |
37 | 00191083016832 | 724-206 | 724-206 | STREAMLINE TL 4.5mm SHORT TAP | HXW | BENDER | 1 | Streamline TL Spinal Fixation System |
38 | 00191083016825 | 724-202 | 724-202 | STRMLN TL, REDUCTION SCREW TEE ADJUSTER | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Streamline TL Spinal Fixation System |
39 | 00191083016818 | 724-200 | 724-200 | STRMLN TL, SCREW ADJUSTER | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Streamline TL Spinal Fixation System |
40 | 00191083016801 | 724-177 | 724-177 | STRMLN TL, PEDICLE FINDER, HALF FLAT TIP | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Streamline TL Spinal Fixation System |
41 | 00191083016795 | 724-112 | 724-112 | STRMLN TL, MODULAR REDUCT SCREW INSRTR | HWR | DRIVER, PROSTHESIS | 1 | Streamline TL Spinal Fixation System |
42 | 00191083016788 | 724-008 | 724-008 | STRMLN TL, SCREW INSRTR, NO SPRING SLACK | HWR | DRIVER, PROSTHESIS | 1 | Streamline TL Spinal Fixation System |
43 | 00191083016771 | 724-001 | 724-001 | STRMLN TL 70mm SLIM PED FINDER, STRAIGHT | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Streamline TL Spinal Fixation System |
44 | 00191083016764 | 723-961 | 723-961 | STRMLN TL, RATCHET TRQ LIMIT T-HANDLE | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Streamline TL Spinal Fixation System |
45 | 00191083016757 | 10-55-PR-RL-130 | 10-55-PR-RL-130 | ROD, PRE-BENT, R.9.5 | KWP,NKB | APPLIANCE, FIXATION, SPINAL INTERLAMINAL,Thoracolumbosacral pedicle screw system | 2 | Streamline TL Spinal Fixation System |
46 | 00191083016740 | 10-55-PR-RL-125 | 10-55-PR-RL-125 | ROD, PRE-BENT, R.9.5 | KWP,NKB | APPLIANCE, FIXATION, SPINAL INTERLAMINAL,Thoracolumbosacral pedicle screw system | 2 | Streamline TL Spinal Fixation System |
47 | 00191083016733 | 10-55-PR-RL-120 | 10-55-PR-RL-120 | ROD, PRE-BENT, R.9.5 | KWP,NKB | APPLIANCE, FIXATION, SPINAL INTERLAMINAL,Thoracolumbosacral pedicle screw system | 2 | Streamline TL Spinal Fixation System |
48 | 00191083016726 | 10-55-PR-RL-115 | 10-55-PR-RL-115 | ROD, PRE-BENT, R.9.5 | KWP,NKB | APPLIANCE, FIXATION, SPINAL INTERLAMINAL,Thoracolumbosacral pedicle screw system | 2 | Streamline TL Spinal Fixation System |
49 | 00191083016719 | 10-55-PR-RL-110 | 10-55-PR-RL-110 | ROD, PRE-BENT, R.9.5 | NKB,KWP | Thoracolumbosacral pedicle screw system,APPLIANCE, FIXATION, SPINAL INTERLAMINAL | 2 | Streamline TL Spinal Fixation System |
50 | 00191083016696 | 10-55-PR-RL-100 | 10-55-PR-RL-100 | ROD, PRE-BENT, R.9.5 | NKB,KWP | Thoracolumbosacral pedicle screw system,APPLIANCE, FIXATION, SPINAL INTERLAMINAL | 2 | Streamline TL Spinal Fixation System |
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 |