No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00382903406616 | 340661 | 340661 | BD® CD3 (SK7) APC | MVU | Reagents, specific, analyte | 1 | N/A |
2 | 30382903051954 | 305195 | 305195 | NEEDLE 18X1 RB | FMI | Needle, hypodermic, single lumen | N/A | |
3 | 30382903051756 | 305175 | 305175 | NEEDLE 20GA 1IN | FMI | Needle, hypodermic, single lumen | N/A | |
4 | 00382906654212 | 665421 | 665421 | Software Kit FACSDiva v9.2 IVD | OYE | Flow cytometric reagents and accessories. | 2 | FACSDiva |
5 | 00382906651273 | 665127 | 665127 | Ki-67 (B56) FITC ASR | MVU | Reagents, specific, analyte | 1 | N/A |
6 | 00382904910907 | 491090 | 491090 | BD FocalPoint Refurbished (120V) | MNM | READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED | 3 | BD FocalPoint Slide Profiler Refurbished |
7 | 00382904429676 | 442967 | 442967 | BD Viper™ LT System PCR Accessory kit | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | BD Viper™ LT System PCR Accessory kit |
8 | 00382904429584 | 442958 | 442958 | BD Viper™ LT System SDA Accessory Kit | OOI | real time Nucleic acid amplification system | 2 | BD Viper™ LT System SDA Accessory Kit |
9 | 00382904428433 | 442843 | 442843 | BD Viper™ System, Remanufactured | LSL | DNA-REAGENTS, NEISSERIA | 2 | BD Viper™ System, Remanufactured |
10 | 00382904428211 | 442821 | 442821 | BD MAX™ ExK™ DNA-3 | JJH | CLINICAL SAMPLE CONCENTRATOR | 1 | BD MAX™ ExK DNA-3 |
11 | 00382904428174 | 442817 | 442817 | BD MAX™ ExK™ DNA-1 | JJH | CLINICAL SAMPLE CONCENTRATOR | 1 | BD MAX™ ExK DNA-1 |
12 | 00382904428051 | 442805 | 442805 | BACTEC Blood Culture Procedural Tray | MDB | SYSTEM, BLOOD CULTURING | 1 | BD BACTEC™ Blood Culture Procedural Tray |
13 | 00382904462505 | 446250 | 446250 | BD Affirm™ Affirm VPIII Sample Collection Sets Contains: 1 each, Sterile S BD Affirm™ Affirm VPIII Sample Collection Sets Contains: 1 each, Sterile Swab, Sample Collection Tube, Sample Collection Tube Cap | LIO | Device, specimen collection | 1 | BD Affirm™ Affirm VPIII Sample Collection Sets |
14 | 00382904061401 | 406140 | 406140 | TRAY EPID SSHP20G3.5 L/PI X3742B | CAZ | Anesthesia conduction kit | 2 | BD perisafe, BD Epilor, BD Luer-Lok |
15 | 00382904061388 | 406138 | 406138 | TRAY EPID SSHP20G3.5 LOR5 L 2T0734 | CAZ | Anesthesia conduction kit | 2 | N/A |
16 | 00382904060770 | 406077 | 406077 | TRAY EPID SSTT17G3.5 LOR5 S/L | CAZ | Anesthesia conduction kit | 2 | N/A |
17 | 00382904060565 | 406056 | 406056 | TRAY EPID SSHP18G3.5 LOR5 S/L | CAZ | Anesthesia conduction kit | 2 | N/A |
18 | 00382904060558 | 406055 | 406055 | Tray EPID SSHP18G3.5 LOR5 L | CAZ | Anesthesia conduction kit | 2 | N/A |
19 | 00382904060305 | 406030 | 406030 | TRAY EPID SSTT17G3.5 LOR5 | CAZ | Anesthesia conduction kit | 2 | N/A |
20 | 00382904060251 | 406025 | 406025 | TRAY EPID CONT TT17G3.5 C19 | CAZ | Anesthesia conduction kit | 2 | N/A |
21 | 00382906651211 | 665121 | 665121 | CD223 (T47-530) PerCP-Cy5.5 ASR | MVU | Reagents, specific, analyte | 1 | N/A |
22 | 00382906651174 | 665117 | 665117 | CD152 (BNI3) PE ASR | MVU | Reagents, specific, analyte | 1 | N/A |
23 | 00382906651167 | 665116 | 665116 | CD42b (HIP1) PE ASR | MVU | Reagents, specific, analyte | 1 | N/A |
24 | 00382906645388 | 664538 | 664538 | BD® CD22 (S-HCL-1) PE-Cy7 | MVU | Reagents, specific, analyte | 1 | N/A |
25 | 00382906645371 | 664537 | 664537 | BD Horizon™ Mouse IgG1 (X40) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
26 | 00382906645364 | 664536 | 664536 | BD Horizon™ Anti-HLA-DR (G46-6) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
27 | 00382906645357 | 664535 | 664535 | BD Horizon™ CD45 (HI30) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
28 | 00382906645340 | 664534 | 664534 | BD Horizon™ CD23 (EBVCS-5) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
29 | 00382906645333 | 664533 | 664533 | BD Horizon™ CD20 (L27) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
30 | 00382906645326 | 664532 | 664532 | BD Horizon™ CD19 (SJ25C1) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
31 | 00382906645319 | 664531 | 664531 | BD Horizon™ CD16 (3G8) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
32 | 00382906645302 | 664530 | 664530 | BD Horizon™ CD8 (SK1) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
33 | 00382906645296 | 664529 | 664529 | BD Horizon™ CD5 (L17F12) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
34 | 00382906645289 | 664528 | 664528 | BD Horizon™ CD4 (SK3) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
35 | 00382906645272 | 664527 | 664527 | BD Horizon™ CD3 (SK7) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
36 | 00382906645265 | 664526 | 664526 | BD Horizon™ Mouse IgG1 (X40) BV711 | MVU | Reagents, specific, analyte | 1 | Horizon |
37 | 00382906645258 | 664525 | 664525 | BD Horizon™ CD123 (9F5) BV711 | MVU | Reagents, specific, analyte | 1 | Horizon |
38 | 00382906645241 | 664524 | 664524 | BD Horizon™ CD56 (NCAM16.2) BV711 | MVU | Reagents, specific, analyte | 1 | Horizon |
39 | 00382906645234 | 664523 | 664523 | BD Horizon™ CD38 (HB7) BV711 | MVU | Reagents, specific, analyte | 1 | Horizon |
40 | 00382906645227 | 664522 | 664522 | BD Horizon™ CD14 (MPhiP9) BV711 | MVU | Reagents, specific, analyte | 1 | Horizon |
41 | 00382906645210 | 664521 | 664521 | BD Horizon™ CD13 (L138) BV711 | MVU | Reagents, specific, analyte | 1 | Horizon |
42 | 00382906645203 | 664520 | 664520 | BD Horizon™ CD10 (HI10a) BV711 | MVU | Reagents, specific, analyte | 1 | Horizon |
43 | 00382906645197 | 664519 | 664519 | BD Horizon™ CD4 (SK3) BV711 | MVU | Reagents, specific, analyte | 1 | Horizon |
44 | 00382906641267 | 664126 | 664126 | BD FACSCanto™ System Software | GKZ,OYE | Counter, differential cell,Flow cytometric reagents and accessories. | 2 | FACSCanto |
45 | 00382906641243 | 664124 | 664124 | BD FACSCanto™ II System Software | OYE,GKZ | Flow cytometric reagents and accessories.,Counter, differential cell | 2 | FACSCanto |
46 | 00382906641229 | 664122 | 664122 | BD FACSCanto™ System Software | GKZ | Counter, differential cell | 2 | FACSCanto |
47 | 00382906641199 | 664119 | 664119 | BD FACSCanto™ Clinical Software v4.0.1 | GKZ | Counter, differential cell | 2 | FACSCanto |
48 | 00382906641144 | 664114 | 664114 | BD FACSCanto™ System Software | GKZ | Counter, differential cell | 2 | FACSCanto |
49 | 00382906641120 | 664112 | 664112 | BD FACSCanto™ System Software | GKZ,OYE | Counter, differential cell,Flow cytometric reagents and accessories. | 2 | FACSCanto |
50 | 00382906641106 | 664110 | 664110 | BD FACSCanto™ II System Software | GKZ,OYE | Counter, differential cell,Flow cytometric reagents and accessories. | 2 | FACSCanto |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 08033837190301 | MAMMOBED | 6100-06M1 | It's a special table on wheels for stereotactic breast biopsy procedures with pa It's a special table on wheels for stereotactic breast biopsy procedures with patient in prone position. | MAMMOBED | I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL |
2 | 08033837190219 | BIOPSY DIGIT AM | 9100-01 | Biopsy Digit device uses two stereo images taken by a digital solid state camera Biopsy Digit device uses two stereo images taken by a digital solid state camera to determine the location of a lesion in three dimensions. It is intended to mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement. | BIOPSY DIGIT | I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL |
3 | 08033837190202 | BIOPSY DIGIT SL | 9201-01 | Biopsy Digit SL is a medical device intended to be used for mamnmographic proced Biopsy Digit SL is a medical device intended to be used for mamnmographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement. | BIOPSY DIGIT | I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL |
4 | 08033837190110 | GIOTTO IMAGE SRA | 6702 | Giotto Image is a conventional film-screen x-ray mammographic device. | GIOTTO IMAGE | I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL |
5 | 08033837190103 | GIOTTO IMAGE M | 6501 | Giotto Image is a conventional film-screen x-ray mammographic device. | GIOTTO IMAGE | I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL |
6 | 07613327059281 | 0502513045 | 0502-513-045 | HD Bariatric Laparoscope, Autoclavable, 45 ¿ View Direction | Precision Ideal Eyes | STRYKER CORPORATION |
7 | 07613327059243 | 0502513010 | 0502-513-010 | HD Bariatric Laparoscope, Autoclavable, 0 ¿ View Direction | Precision Ideal Eyes | STRYKER CORPORATION |
8 | 07613327059182 | 0502513030 | 0502-513-030 | HD Bariatric Laparoscope, Autoclavable, 30 ¿ View Direction | Precision Ideal Eyes | STRYKER CORPORATION |
9 | 06430035430055 | Sophie Classic | Planmed Sophie Classic is a mammographic x-ray unit intended for diagnosis of br Planmed Sophie Classic is a mammographic x-ray unit intended for diagnosis of breast cancer. | Planmed | PLANMED OY | |
10 | 05414904009802 | MAMORAY HD 24X30 | EDBVA | MAMORAY CASSETTE / HD | MAMORAY HD | AGFA |
11 | 05414904009796 | MAMORAY HD S 18X24 | EDBZJ | MAMORAY CASSETTE / HD S | MAMORAY HD S | AGFA |
12 | 05414904009345 | MAMORAY HD 24X30 | EDBU7 | MAMORAY CASSETTE / HD | MAMORAY HD | AGFA |
13 | 05414904008966 | MAMORAY HD S 18X24 | EDB1L | MAMORAY CASSETTE / HD S | MAMORAY HD S | AGFA |
14 | 05414904008959 | MAMORAY HD S 24X30 | EDB3P | MAMORAY CASSETTE / HD S | MAMORAY HD S | AGFA |
15 | 05414904008942 | MAMORAY HD S 24X30 | EDB4R | MAMORAY CASSETTE / HD S | MAMORAY HD S | AGFA |
16 | 05414904008898 | MAMORAY HD 18X24 | EDBQY | MAMORAY CASSETTE / HD | MAMORAY HD | AGFA |
17 | 05414904008881 | MAMORAY HD 18X24 | EDBR1 | MAMORAY CASSETTE / HD | MAMORAY HD | AGFA |
18 | 00841911101581 | MMT100 | Stereotactic X-Ray Breast Biopsy Table System | Mammotome MammoTest | DEVICOR MEDICAL PRODUCTS, INC. | |
19 | 00840682123297 | EST6 | Senographe Essential Stereotaxy | GE MEDICAL SYSTEMS | ||
20 | 00815137021251 | 311S | Protective Coverlets for Mammography - 29.2cm x 33.0cm | Bella Blankets | BEEKLEY CORPORATION | |
21 | 00815137021244 | 310S | Protective Coverlets for Mammography - 22.9cm x 27.9cm | Bella Blankets | BEEKLEY CORPORATION | |
22 | 00815137020247 | 311 | Protective Coverlets for Mammography - 29.2cm x 33.0cm | Bella Blankets | BEEKLEY CORPORATION | |
23 | 00815137020230 | 310 | Protective Coverlets for Mammography - 22.9cm x 27.9cm | Bella Blankets | BEEKLEY CORPORATION | |
24 | 00813079020424 | LNGO-2022 | LNGO-2022 | 20/22ga (0.9/0.7mm) | Open Needle Guide | REMINGTON MEDICAL, INC. |
25 | 00813079020417 | LNGC-2022 | LNGC-2022 | 20/22ga (0.9/0.7mm) | Closed Needle Guide | REMINGTON MEDICAL, INC. |
26 | 00813079020400 | LNGC-14 | LNGC-14 | 14ga (2.1mm) | Closed Needle Guide | REMINGTON MEDICAL, INC. |
27 | B852SPECBOARD4440 | 444 | Device Classification Name System, X-Ray, Mammographic510(K) Number K891090 | Specboard | MACBRUD CORPORATION | |
28 | B852SPECBOARD2220 | 222 | Device Classification Name System, X-Ray, Mammographic510(K) Number K123414Devic Device Classification Name System, X-Ray, Mammographic510(K) Number K123414Device Name SPECBOARD JR. | SPECBOARD JR | MACBRUD CORPORATION | |
29 | 45420045505811 | MP301-T | MP301-T | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
30 | 45420045505804 | MP301-D | MP301-D | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
31 | 45420045505798 | MP301 | MP301 | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
32 | 45420045505781 | MP201 | MP201 | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
33 | 45420045505668 | MP101 | MP101 | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
34 | 30382904094097 | 409409 | 409409 | NEEDLE BIOPSY S/SU 20GA 1-1/2IN BREAST | BD PrecisionGlide | BECTON, DICKINSON AND COMPANY |
35 | 30382904094080 | 409408 | 409408 | NEEDLE BIOPSY S/SU 20GA 2-1/2IN BREAST | BD PrecisionGlide | BECTON, DICKINSON AND COMPANY |
36 | 30382904094073 | 409407 | 409407 | NEEDLE BIOPSY S/SU 20GA 3-1/2IN BREAST | BD PrecisionGlide | BECTON, DICKINSON AND COMPANY |
37 | 25420045507347 | MP201-10 | MammoPad Radiolucent Cushion | HOLOGIC, INC. | ||
38 | 25420045507330 | MP301-10 | MammoPad Radiolucent Cushion | HOLOGIC, INC. | ||
39 | 25420045506951 | MP301-T | MP301-T | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
40 | 25420045506944 | MP301-D | MP301-D | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
41 | 15420045512948 | AFFIRM™ CONTRAST BIOPSY SOFTWARE | AFFIRM™ CONTRAST BIOPSY | HOLOGIC, INC. | ||
42 | 15420045512931 | AFFIRM™ SPECIMEN IMAGING | AFFIRM™ SPECIMEN IMAGING | HOLOGIC, INC. | ||
43 | 15420045510869 | PBX-SYS-AFFIRM-2D | PBX-SYS-AFFIRM-2D | Affirm Prone Biopsy System | HOLOGIC, INC. | |
44 | 15420045510852 | PBX-SYS-AFFIRM-2D | PBX-SYS-AFFIRM-2D | Affirm Prone Biopsy System | HOLOGIC, INC. | |
45 | 15420045510845 | PBX-SYS-AFFIRM-2D | PBX-SYS-AFFIRM-2D | Affirm Prone Biopsy System | HOLOGIC, INC. | |
46 | 15420045507197 | ASY-03669 | ASY-03669 | Affirm Breast Biopsy Guidance System | HOLOGIC, INC. | |
47 | 15420045507180 | ASY-03668 | ASY-03668 | Affirm Breast Biopsy Guidance System | HOLOGIC, INC. | |
48 | 15420045507173 | ASY-03667 | ASY-03667 | Affirm Breast Biopsy Guidance System | HOLOGIC, INC. | |
49 | 15420045506831 | ASY-05205 | ASY-05205 | Affirm Lateral Arm Upright Biopsy Accessory | HOLOGIC, INC. | |
50 | 15420045506824 | ASY-09644 | ASY-09644 | Affirm Lateral Arm Upright Biopsy Accessory | HOLOGIC, INC. |