| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 04250195600905 | 272015 | MIJ | Needle, Tumor Localization | 1 | Lung Marker System | ||
| 2 | 04250195600899 | 272012 | MIJ | Needle, Tumor Localization | 1 | Lung Marker System | ||
| 3 | 04250195611307 | Tumark-BREV-S-X | Tumark-BREV-S-X | NEU | Marker, Radiographic, Implantable | 2 | Tumark® Professional X for Brevera® Standard | |
| 4 | 04250195611291 | Tumark-BREV-P-Vision | Tumark-BREV-P-Vision | NEU | Marker, Radiographic, Implantable | 2 | Tumark® Vision for Brevera® Petite | |
| 5 | 04250195611284 | Tumark-BREV-S-Vision | Tumark-BREV-S-Vision | NEU | Marker, Radiographic, Implantable | 2 | Tumark® Vision for Brevera® Standard | |
| 6 | 04250195611277 | Tumark-E13-P-Q | Tumark-E13-P-Q | NEU | Marker, Radiographic, Implantable | 2 | Tumark® Professional Q for Eviva® Petite | |
| 7 | 04250195611246 | Tumark-E13-S-X | Tumark-E13-S-X | NEU | Marker, Radiographic, Implantable | 2 | Tumark® Professional X for Eviva® Standard | |
| 8 | 04250195611239 | Tumark-E13-P-Vision | Tumark-E13-P-Vision | NEU | Marker, Radiographic, Implantable | 2 | Tumark® Vision for Eviva® Petite | |
| 9 | 04250195611406 | 271992 | MIJ | Needle, Tumor Localization | 1 | Duo System Stereo | ||
| 10 | 04250195611383 | 271991 | MIJ | Needle, Tumor Localization | 1 | Duo System Stereo | ||
| 11 | 04250195601841 | 900118 | KNW | Instrument, Biopsy | Biopsy Handy | |||
| 12 | 04250195601605 | 601649 | MIJ | Needle, Tumor Localization | 1 | MRI Tuloc | ||
| 13 | 04250195601926 | 900138 | KNW | Instrument, Biopsy | 2 | Biopsy Handy | ||
| 14 | 04250195601919 | 900136 | KNW | Instrument, Biopsy | Biopsy Handy | |||
| 15 | 04250195601902 | 900134 | KNW | Instrument, Biopsy | 2 | Biopsy Handy | ||
| 16 | 04250195611260 | Tumark-E13-S-Q | Tumark-E13-S-Q | NEU | Marker, Radiographic, Implantable | 2 | Tumark® Professional Q for Eviva® Standard | |
| 17 | 04250195601612 | 601651 | MIJ | Needle, Tumor Localization | 1 | MRI Tuloc | ||
| 18 | 04250195601896 | 900130 | KNW | Instrument, Biopsy | 2 | Biopsy Handy | ||
| 19 | 04250195611932 | 351282 | NEU | Marker, Radiographic, Implantable | 2 | Tumark Professional | ||
| 20 | 04250195611925 | 351280 | NEU | Marker, Radiographic, Implantable | 2 | Tumark Professional | ||
| 21 | 04250195601957 | 900146 | KNW | Instrument, Biopsy | 2 | Biopsy Handy | ||
| 22 | 04250195601940 | 900144 | KNW | Instrument, Biopsy | 2 | Biopsy Handy | ||
| 23 | 04250195601933 | 900142 | KNW | Instrument, Biopsy | 2 | Biopsy Handy | ||
| 24 | 04250195601889 | 900128 | KNW | Instrument, Biopsy | 2 | Biopsy Handy | ||
| 25 | 04250195601872 | 900126 | KNW | Instrument, Biopsy | 2 | Biopsy Handy | ||
| 26 | 04250195601865 | 900122 | KNW | Instrument, Biopsy | 2 | Biopsy Handy | ||
| 27 | 04250195601858 | 900120 | KNW | Instrument, Biopsy | 2 | Biopsy Handy | ||
| 28 | 04250195600806 | 271550 | 271550 | NEU | Marker, Radiographic, Implantable | 2 | TUMARK | |
| 29 | 04250195611215 | 351252 | 351252 | NEU | Marker, Radiographic, Implantable | TUMARK Flex | ||
| 30 | 04250195611208 | 351250 | 351250 | NEU | Marker, Radiographic, Implantable | TUMARK Flex | ||
| 31 | 04250195602275 | 271557 | 271557 | NEU | Marker, Radiographic, Implantable | TUMARK Professional | ||
| 32 | 04250195602268 | 271559 | 271559 | NEU | Marker, Radiographic, Implantable | TUMARK Professional | ||
| 33 | 04250195602213 | 271576 | 271576 | NEU | Marker, Radiographic, Implantable | 2 | TUMARK Flex | |
| 34 | 04250195602206 | 271574 | 271574 | NEU | Marker, Radiographic, Implantable | TUMARK Flex | ||
| 35 | 04250195602190 | 271572 | 271572 | NEU | Marker, Radiographic, Implantable | 2 | TUMARK Flex | |
| 36 | 04250195602183 | 271570 | 271570 | NEU | Marker, Radiographic, Implantable | 2 | TUMARK Flex | |
| 37 | 04250195600820 | 271565 | 271565 | NEU | Marker, Radiographic, Implantable | 2 | TUMARK Professional | |
| 38 | 04250195600813 | 271560 | 271560 | NEU | Marker, Radiographic, Implantable | 2 | TUMARK Professional | |
| 39 | 04250195602350 | 601570 | 601570 | NEU | Marker, Radiographic, Implantable | 2 | Tumark MRI | |
| 40 | 04250195611550 | 271640 | MIJ | Needle, Tumor Localization | 1 | Tuflex | ||
| 41 | 04250195611468 | 601590 | NEU | Marker, Radiographic, Implantable | 2 | Tumark Vision MRI | ||
| 42 | 04250195611598 | 271642 | MIJ | Needle, Tumor Localization | 1 | Tuflex | ||
| 43 | 04250195611222 | Tumark-E13-S-Vision | Tumark-E13-S-Vision | NEU | Marker, Radiographic, Implantable | 2 | Tumark® Vision for Eviva® Standard | |
| 44 | 04250195611574 | 271641 | MIJ | Needle, Tumor Localization | 1 | Tuflex | ||
| 45 | 04250195611819 | 351272 | NEU | Marker, Radiographic, Implantable | 2 | Tumark Sphera | ||
| 46 | 04250195611802 | 351270 | NEU | Marker, Radiographic, Implantable | 2 | Tumark Sphera | ||
| 47 | 04250195611697 | 271530 | NEU | Marker, Radiographic, Implantable | Tumark Sphera | |||
| 48 | 04250195611611 | 271643 | MIJ | Needle, Tumor Localization | 1 | Tuflex | ||
| 49 | 04250195602282 | 271549 | 271549 | NEU | Marker, Radiographic, Implantable | 2 | TUMARK Professional X-Shape | |
| 50 | 04250195603029 | 271462 | MIJ | Needle, Tumor Localization | 1 | Q-Wire System |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | B53630001 | 3000 | EchoMark is an implantable ultrasound surgical site marker for soft tissue. The EchoMark is an implantable ultrasound surgical site marker for soft tissue. The marker is comprised of a bioresorbable polymer. | EchoMark | SONAVEX, INC. | |
| 2 | B53620001 | 2000 | EchoMark LP is an implantable ultrasound surgical site marker for soft tissue. T EchoMark LP is an implantable ultrasound surgical site marker for soft tissue. The marker is comprised of a bioresorbable polymer. | EchoMark LP | SONAVEX, INC. | |
| 3 | B033K9536N0 | Nitinol Version | Bari Ring | KAPP SURGICAL INSTRUMENT CO. | ||
| 4 | 15420045514065 | F0405 | BioZorb | HOLOGIC, INC. | ||
| 5 | 15420045514058 | F0404 | BioZorb | HOLOGIC, INC. | ||
| 6 | 15420045514041 | F0331 | BioZorb | HOLOGIC, INC. | ||
| 7 | 15420045514034 | F0231 | BioZorb | HOLOGIC, INC. | ||
| 8 | 15420045514027 | F0221 | BioZorb | HOLOGIC, INC. | ||
| 9 | 15420045514010 | F0304 | BioZorb | HOLOGIC, INC. | ||
| 10 | 15420045514003 | F0303 | BioZorb | HOLOGIC, INC. | ||
| 11 | 15420045513990 | F0203 | BioZorb | HOLOGIC, INC. | ||
| 12 | 15420045513983 | F0202 | BioZorb | HOLOGIC, INC. | ||
| 13 | 10885403242373 | M1815 | M1815 | Achieve Gold Tissue Marker 18g 15cm | Achieve | CAREFUSION 2200, INC |
| 14 | 10885403242366 | M1811 | M1811 | Achieve Gold Tissue Marker, 18g 11cm | Achieve | CAREFUSION 2200, INC |
| 15 | 10885403242359 | M1415 | M1415 | Achieve Gold Tissue Marker, 14g 15cm | Achieve | CAREFUSION 2200, INC |
| 16 | 10885403242342 | M1411 | M1411 | Achieve Gold Tissue Marker, 14g x 11cm | Achieve | CAREFUSION 2200, INC |
| 17 | 10851674008215 | SMARTCLIP LITE, PURPLE, 10CM | SMARTCLIPLT-PURP-10 | Soft tissue marker and delivery system, Purple, 10cm | SmartClip | ELUCENT MEDICAL, INC. |
| 18 | 10851674008208 | SMARTCLIP LITE, PURPLE, 7.5CM | SMARTCLIPLT-PRP-7.5 | Soft tissue marker and delivery system, Purple, 7.5cm | SmartClip | ELUCENT MEDICAL, INC. |
| 19 | 10851674008192 | SMARTCLIP LITE, PURPLE, 5CM | SMARTCLIPLT-PURP-5 | Soft tissue marker and delivery system, Purple, 5cm | SmartClip | ELUCENT MEDICAL, INC. |
| 20 | 10851674008185 | SMARTCLIP LITE, GREEN, 10CM | SMARTCLIPLT-GRN-10 | Soft tissue marker and delivery system - Green, 10cm | SmartClip | ELUCENT MEDICAL, INC. |
| 21 | 10851674008178 | SMARTCLIP LITE, GREEN, 7.5CM | SMARTCLIPLT-GRN-7.5 | Soft tissue marker and delivery system - Green, 7.5cm | SmartClip | ELUCENT MEDICAL, INC. |
| 22 | 10851674008161 | SMARTCLIP LITE, PINK, 10CM | SMARTCLIPLT-PNK-10 | Soft tissue marker and delivery system - Pink, 10cm | SmartClip | ELUCENT MEDICAL, INC. |
| 23 | 10851674008154 | SMARTCLIP LITE, PINK, 7.5CM | SMARTCLIPLT-PNK-7.5 | Soft tissue marker and delivery system - Pink, 7.5cm | SmartClip | ELUCENT MEDICAL, INC. |
| 24 | 10851674008147 | SMARTCLIP LITE, PINK, 5CM | SMARTCLIPLT-PNK-5 | Soft tissue marker and delivery system - Pink, 5cm | SmartClip | ELUCENT MEDICAL, INC. |
| 25 | 10851674008130 | SMARTCLIP LITE, GREEN, 5CM | SMARTCLIPLT-GRN-5 | Soft tissue marker and delivery system - Green, 5cm | SmartClip | ELUCENT MEDICAL, INC. |
| 26 | 10851674008086 | SMARTCLIP-PINK-10 | SMARTCLIP-PINK-10 | Soft Tissue Marker and Delivery System - PINK (Revised Frequency) | SmartClip | ELUCENT MEDICAL, INC. |
| 27 | 10851674008024 | SMARTCLIP-PURP-10 | SMARTCLIP-PURP-10 | Soft Tissue Marker and Delivery System - PURPLE | SmartClip | ELUCENT MEDICAL, INC. |
| 28 | 10851674008017 | SMARTCLIP-GRN-10 | SMARTCLIP-GRN-10 | Soft Tissue Marker and Delivery System - GREEN | SmartClip | ELUCENT MEDICAL, INC. |
| 29 | 10851674008000 | SMARTCLIP-PINK-10 | SMARTCLIP-PINK-10 | Soft Tissue Marker and Delivery System - PINK | SmartClip | ELUCENT MEDICAL, INC. |
| 30 | 10085167400822 | ENVISIO-HUD2 | ENVISIO-HUD2 | EnVisio Navigation System Heads Up Display Version 2 | EnVisio | ELUCENT MEDICAL, INC. |
| 31 | 05420045503994 | SMARK-M-SS3 | SMARK-M-SS3 | SecurMark MRI | HOLOGIC, INC. | |
| 32 | 05420045503987 | SMARK-M-SS2 | SMARK-M-SS2 | SecurMark MRI | HOLOGIC, INC. | |
| 33 | 05420045503970 | SMARK-M-SS1 | SMARK-M-SS1 | SecurMark MRI | HOLOGIC, INC. | |
| 34 | 05420045503963 | SMARK-E10-SS3 | SMARK-E10-SS3 | SecurMark | HOLOGIC, INC. | |
| 35 | 05420045503956 | SMARK-E10-SS2 | SMARK-E10-SS2 | SecurMark | HOLOGIC, INC. | |
| 36 | 05420045503949 | SMARK-E10-SS1 | SMARK-E10-SS1 | SecurMark | HOLOGIC, INC. | |
| 37 | 05420045503932 | SMARK-E13-SS3 | SMARK-E13-SS3 | SecurMark | HOLOGIC, INC. | |
| 38 | 05420045503925 | SMARK-E13-SS2 | SMARK-E13-SS2 | SecurMark | HOLOGIC, INC. | |
| 39 | 05420045503918 | SMARK-E13-SS1 | SMARK-E13-SS1 | SecurMark | HOLOGIC, INC. | |
| 40 | 05420045503901 | SMARK-U-SS3 | SMARK-U-SS3 | SecurMark | HOLOGIC, INC. | |
| 41 | 05420045503895 | SMARK-U-SS2 | SMARK-U-SS2 | SecurMark | HOLOGIC, INC. | |
| 42 | 05420045503888 | SMARK-U-SS1 | SMARK-U-SS1 | SecurMark | HOLOGIC, INC. | |
| 43 | 05420045503871 | SMARK-A1309-SS2 | SMARK-A1309-SS2 | SecurMark for ATEC | HOLOGIC, INC. | |
| 44 | 05420045503864 | SMARK-A1309-SS1 | SMARK-A1309-SS1 | SecurMark for ATEC | HOLOGIC, INC. | |
| 45 | 05420045503857 | SMARK-A1312-SS2 | SMARK-A1312-SS2 | SecurMark for ATEC | HOLOGIC, INC. | |
| 46 | 05420045503840 | SMARK-A1312-SS1 | SMARK-A1312-SS1 | SecurMark for ATEC | HOLOGIC, INC. | |
| 47 | 05420045503833 | SMARK-A3609-SS3 | SMARK-A3609-SS3 | SecurMark for ATEC | HOLOGIC, INC. | |
| 48 | 05420045503826 | SMARK-A3609-SS2 | SMARK-A3609-SS2 | SecurMark for ATEC | HOLOGIC, INC. | |
| 49 | 05420045503819 | SMARK-A3609-SS1 | SMARK-A3609-SS1 | SecurMark for ATEC | HOLOGIC, INC. | |
| 50 | 05420045503628 | SMARK-EVIVA-2S-13 | SMARK-EVIVA-2S-13 | SecurMark | HOLOGIC, INC. |