No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00814247020727 | VPBB15014100 | BoogieBaby nasal aspirator – standard tip with cover | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – standard tip with cover | ||
2 | 00814247020680 | VPBB15011100 | BoogieBaby nasal aspirator – preemie tip | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – preemie tip | ||
3 | 00814247020444 | ROM-6000 | ROM Plus® Complete Kit Fetal Membranes Rupture Test | NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | 1 | ROM Plus®, Fetal Membranes Rupture Collection Kit | |
4 | 30814247020346 | PRS-0530 | Traxi Panniculus Retractor with Retentus Technology (BMI 30-50) | CCX | Support, Patient Position | traxi® Panniculus Retractorhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetai | ||
5 | 00814247020147 | DSD-2000 | ClearView accessory - Disposable Sound Dilator | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView | |
6 | 00814247020130 | DSD-1000 | Sound/Dilator (accessory for ClearView Uterine Manipulator) | LKF | Cannula, Manipulator/Injector, Uterine | ClearView | ||
7 | 00814247021083 | VPBB150112100 | BoogieBaby nasal aspirator – olive tip 4.5 inch long | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – olive tip 4.5 inch long | ||
8 | 00814247020734 | VPBB15015100 | BoogieBaby nasal aspirator – flair tip | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – flair tip | ||
9 | 00814247020697 | VPBB15012100 | BoogieBaby nasal aspirator – preemie tip with cover | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – preemie tip with cover | ||
10 | 00814247020468 | ROM-QCS | ROM Plus®, Easy Strip Quality Control for Fetal Membranes Rupture Test | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | ROM Plus® Strip Quality Control | |
11 | 00814247020604 | UM900 | ClearView Uterine Manipulator, 9cm | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView Uterine Manipulator | |
12 | 00814247020482 | UM202 | ClearView Uterine Manipulator, long tip | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView Uterine Manipulator | |
13 | 00814247020475 | UM201 | ClearView Uterine Manipulator, regular tip | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView Uterine Manipulator | |
14 | 00814247021090 | VPBB150113100 | BoogieBaby nasal aspirator – olive tip 3.25 inch long | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – olive tip 3.25 inch long | ||
15 | 00814247020857 | ROM-6025 | ROM Plus Cassette/Collection Kit | NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | 1 | ROM Plus, Quality Control for Fetal Membranes Rupture Tes | |
16 | 00814247020451 | ROM-QC | ROM Plus®, Quality Control for Fetal Membranes Rupture Test | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | ROM Plus® Quality Control Kit | |
17 | 00814247020284 | KDT-1000 | Koala Toco® Single-Use Tocodyamometer | HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | 2 | Koala Toco® | |
18 | 00814247020017 | UM700 | ClearView Uterine Manipulator, 7cm | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView Uterine Manipulator | |
19 | 00814247020666 | VAC-6000S | Kiwi® Vacuum Delivery System ProCup® | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® ProCup® | |
20 | 00814247021106 | VPBB150114100 | BoogieBaby nasal aspirator – olive tip 4.5 inch with cover | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – olive tip 4.5 inch with cover | ||
21 | 00814247020802 | PRS-EVAL | Traxi Panniculus Retractor with Retentus Technology | CCX | Support, Patient Position | traxi® Panniculus Retractor | ||
22 | 00814247020345 | PRS-1030 | Traxi Panniculus Retractor with Retentus Technology (BMI 30-50) | CCX | Support, Patient Position | 1 | traxi® Panniculus Retractor | |
23 | 00814247020659 | VAC-6000MTE | Kiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® OmniCup® | |
24 | 00814247020642 | VAC-6000MT | Kiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® OmniCup® | |
25 | 00814247020635 | VAC-6000ME | Kiwi® Vacuum Delivery System, OmniCup® | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® OmniCup® | |
26 | 00814247020628 | VAC-6000C | Kiwi® Vacuum Delivery System, Omni-C Cup® for Cesarean Section | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® Omni-C Cup® | |
27 | 00814247020611 | UM950 | ClearView Total Uterine Manipulator, 9cm tip | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView Total Uterine Manipulator | |
28 | 00814247020499 | UM750 | ClearView Total Uterine Manipulator, regular tip (7cm) | LKF | Cannula, Manipulator/Injector, Uterine | ClearView Total Uterine Manipulator | ||
29 | 00814247020710 | VPBB15013100 | BoogieBaby nasal aspirator – standard tip | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – standard tip | ||
30 | 00814247020437 | ROM-5025 | ROM Plus® Complete Kit Fetal Membranes Rupture Test | NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | 1 | ROM Plus®, Fetal Membranes Rupture Test | |
31 | 00814247020420 | ROM-5000 | ROM Plus® Complete Test Kit | NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | 1 | ROM Plus®, Fetal Membranes Rupture Test | |
32 | 00814247020406 | ROM-1025 | ROM Plus® Easy Strip Complete Kit Fetal Membranes Rupture Test | NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | ROM Plus®, Fetal Membranes Rupture Test | ||
33 | 00814247020093 | CIRC-1350 | AccuCirc® Circumcision Device | HFX | Clamp, Circumcision | 2 | AccuCirc® | |
34 | 00814247020079 | CIRC-1300 | AccuCirc® Circumcision Device | HFX | Clamp, Circumcision | 2 | AccuCirc® | |
35 | 00814247020055 | CIRC-1150 | AccuCirc® Circumcision Device | HFX | Clamp, Circumcision | 2 | AccuCirc® | |
36 | 00814247020031 | CIRC-1100 | AccuCirc® Circumcision Device | HFX | Clamp, Circumcision | AccuCirc® | ||
37 | 00814247020000 | VAC-6000M | Kiwi® Vacuum Delivery System, OmniCup® | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® OmniCup® | |
38 | 00814247020277 | IPC-5090 | Cables to IUP catheters: Edan F6 | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
39 | 00814247020260 | IPC-5080 | Cables to IUP catheters: Philips Avalon | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
40 | 00814247020253 | IPC-5061 | Cables to IUP catheters | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
41 | 00814247020246 | IPC-5060 | Cables to IUP catheters: Neoventa | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
42 | 00814247020239 | IPC-5050 | Cables to IUP catheters: Space Labs Medical 94000 | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
43 | 00814247020222 | IPC-5018 | Cables to IUP catheters: HP8040A 40mV | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
44 | 00814247020215 | IPC-5016 | Cables to IUP catheters: Litton Air-Shields Fetascan 1400 | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
45 | 00814247020208 | IPC-5014 | Cables to IUP catheters: GE Coro 115/116/118 | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
46 | 00814247020192 | IPC-5012 | Cables to IUP catheters: HP8040A 5mV/1350 | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
47 | 30814247020360 | PRS-0550 | Traxi Extender with Retentus Technology (BMI>50 - used with PH-25) | CCX | Support, Patient Position | traxi® Panniculus Retractor Extender | ||
48 | 00814247020598 | SBT-7019 | Cables to FSE | HGP | Electrode, Circular (Spiral), Scalp And Applicator | 2 | FSE Cables | |
49 | 00814247020581 | SBT-7018 | Cables to FSE | HGP | Electrode, Circular (Spiral), Scalp And Applicator | 2 | FSE Cables | |
50 | 00814247020574 | SBT-7017 | Cables to FSE | HGP | Electrode, Circular (Spiral), Scalp And Applicator | 2 | FSE Cables |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00840180511855 | CI-11106-02 | LTP A-arm Extension Female Adapter | General Instrument | ALPHATEC SPINE, INC. | |
2 | 00840180511848 | CI-11106-01 | LTP A-arm Extension Male Adapter | General Instrument | ALPHATEC SPINE, INC. | |
3 | 00840180511442 | CI-11037-20 | Right Angle Flexible A-Arm Adapter - Short | General Instrument | ALPHATEC SPINE, INC. | |
4 | 00840180511435 | CI-11037-10 | Right Angle Flexible A-Arm Adapter - Long | General Instrument | ALPHATEC SPINE, INC. | |
5 | 00840180510032 | CI-10901 | A-Arm Modular Attachment Adapter | General Instrument | ALPHATEC SPINE, INC. | |
6 | 00840180505748 | CI-10852-4001-1 | Pad, Rectangular, Rectangular, Paddle, LIF-PTP, 6x4x1" | General Instrument | ALPHATEC SPINE, INC. | |
7 | 00840180505731 | CI-10852-4000 | Pad, Rectangular, Thoracic, LIF-PTP, 16x6x2" | General Instrument | ALPHATEC SPINE, INC. | |
8 | 00840180505724 | CI-10852-4001-2 | Pad, Rectangular, Pelvic, LIF-PTP, 9x5.5x2" | General Instrument | ALPHATEC SPINE, INC. | |
9 | 00840180500675 | CI-10624 | Tedan ALIF Adapter Arm | General Instruments | ALPHATEC SPINE, INC. | |
10 | 00840180500224 | CI-10594 | Distractor Rack, A-Arm Quick Connect | General Instruments | ALPHATEC SPINE, INC. | |
11 | 00840155412231 | MS-ST612 | Not Applicable | Limb Restraint, Adult | MedSource Straps | MEDSOURCE INTERNATIONAL LLC |
12 | 00840155412224 | MS-ST610 | Not Applicable | Patient Restraint Waist Strap, Burgundy | MedSource Straps | MEDSOURCE INTERNATIONAL LLC |
13 | 00840155412200 | MS-ST11PT_2 | Not Applicable | Multi-Color 11 Point Strap | MedSource Straps | MEDSOURCE INTERNATIONAL LLC |
14 | 00840155408524 | BT-91010 | Not Applicable | Instant Immobilizer, Adult | MedSource Immobilizer | MEDSOURCE INTERNATIONAL LLC |
15 | 00840155408500 | BT-91012 | Not Applicable | Instant Immobilizer, Child | MedSource Immobilizer | MEDSOURCE INTERNATIONAL LLC |
16 | 00840155408487 | BT-91014 | Not Applicable | Instant Immobilizer, Infant | MedSource Immobilizer | MEDSOURCE INTERNATIONAL LLC |
17 | 00840155408333 | MS-91002 | Not Applicable | Head Immobilizer Blocks (2) | MedSource Head Immobilizer Block | MEDSOURCE INTERNATIONAL LLC |
18 | 00840155408319 | MS-91003 | Not Applicable | Head Immobilizer Base | MedSource Head Immobilizer Base | MEDSOURCE INTERNATIONAL LLC |
19 | 00840155408210 | MS-91001 | Not Applicable | Head Immobilizer Straps (2) | MedSource Head Immobilizer Straps | MEDSOURCE INTERNATIONAL LLC |
20 | 00840155408180 | MS-92262 | Not Applicable | Foam Insert for Extrication Device | MedSource Foam Insert for Extrication Device | MEDSOURCE INTERNATIONAL LLC |
21 | 00840155408173 | MS-ED3000 | Not Applicable | Extrication Device, Red | MedSource Extrication Device | MEDSOURCE INTERNATIONAL LLC |
22 | 00840155408166 | MS-ED2255 | Not Applicable | Extrication Device, Pediatric | MedSource Extrication Device | MEDSOURCE INTERNATIONAL LLC |
23 | 00840155408159 | STORM-ED2253 | Not Applicable | Extrication Device, MedStorm | MedSource Extrication Device | MEDSOURCE INTERNATIONAL LLC |
24 | 00840155408128 | MS-2312-S | Not Applicable | Deluxe Fracture Care Kit (8) Splints | MedSource Fracture Kit | MEDSOURCE INTERNATIONAL LLC |
25 | 00840155405929 | MS-95015 | Not Applicable | Braid Strap | MedSource Straps | MEDSOURCE INTERNATIONAL LLC |
26 | 00840155405912 | MS-95010 | Not Applicable | Multi Strap Saver | MedSource Straps | MEDSOURCE INTERNATIONAL LLC |
27 | 00840155405905 | MS-95002 | Not Applicable | Multi-Strap Strapping System, Black | MedSource Straps | MEDSOURCE INTERNATIONAL LLC |
28 | 00840155405806 | MS-92500 | Not Applicable | Adjustable Extrication Collar, Adult | MedSource Extrication Collar | MEDSOURCE INTERNATIONAL LLC |
29 | 00840155405769 | MS-91014 | Not Applicable | Instant Immobilizer, Infant | MedSource Immobilizer | MEDSOURCE INTERNATIONAL LLC |
30 | 00840155405387 | MS-91010 | Not Applicable | Instant Immobilizer, Adult | MedSource Immobilizer | MEDSOURCE INTERNATIONAL LLC |
31 | 00840155405363 | MS-91000-RCS | Not Applicable | Head Immobilizer | MedSource Head Immobilizer | MEDSOURCE INTERNATIONAL LLC |
32 | 00840155405349 | MS-91000-PC | Not Applicable | Head Immobilizer Pesco Label | MedSource Head Immobilizer | MEDSOURCE INTERNATIONAL LLC |
33 | 00840155405325 | MS-91000 | Not Applicable | Head Immobilizer | MedSource Head Immobilizer | MEDSOURCE INTERNATIONAL LLC |
34 | 00840155404014 | MS-ED2253-DO | Not Applicable | Extrication Device ONLY, No Bag | MedSource Extrication Device | MEDSOURCE INTERNATIONAL LLC |
35 | 00840155403970 | MS-ED2253-RCS | Not Applicable | Extrication Device | MedSource Extrication Device | MEDSOURCE INTERNATIONAL LLC |
36 | 00840155403963 | MS-ED2253-PC | Not Applicable | Extrication Device, Bomberos | MedSource Extrication Device | MEDSOURCE INTERNATIONAL LLC |
37 | 00840155403956 | MS-ED2253 | Not Applicable | Extrication Device, Green | MedSource Extrication Device | MEDSOURCE INTERNATIONAL LLC |
38 | 00840155403888 | MS-EX600 | Not Applicable | Extrication Collar, Tall | MedSource Extrication Collar | MEDSOURCE INTERNATIONAL LLC |
39 | 00840155403864 | MS-EX500 | Not Applicable | Extrication Collar, Regular | MedSource Extrication Collar | MEDSOURCE INTERNATIONAL LLC |
40 | 00840155403840 | MS-EX400 | Not Applicable | Extrication Collar, Neckless | MedSource Extrication Collar | MEDSOURCE INTERNATIONAL LLC |
41 | 00840155403826 | MS-EX300 | Not Applicable | Extrication Collar, Short | MedSource Extrication Collar | MEDSOURCE INTERNATIONAL LLC |
42 | 00840155403802 | MS-EX200 | Not Applicable | Extrication Collar, Pediatric | MedSource Extrication Collar | MEDSOURCE INTERNATIONAL LLC |
43 | 00840155403789 | MS-EX100 | Not Applicable | Extrication Collar, Infant | MedSource Extrication Collar | MEDSOURCE INTERNATIONAL LLC |
44 | 00840113231003 | 711501 | Intended to support and maintain the position of an anesthetized patient during surgery | Dr. Don's Arm Canoe; Velcro | ASPEN SURGICAL PRODUCTS, INC. | |
45 | 00840113230921 | 715100 | Intended to support and maintain the position of an anesthetized patient during surgery | Seattle Brachy Bed | ASPEN SURGICAL PRODUCTS, INC. | |
46 | 00840113230914 | 715000 | Intended to support and maintain the position of an anesthetized patient during surgery | MD Traction Rope | ASPEN SURGICAL PRODUCTS, INC. | |
47 | 00840113230907 | 714200 | Intended to support and maintain the position of an anesthetized patient during surgery | Sedona Arm Positioner Set | ASPEN SURGICAL PRODUCTS, INC. | |
48 | 00840113230891 | 714100 | Intended to support and maintain the position of an anesthetized patient during surgery | Prone Face Pillow | ASPEN SURGICAL PRODUCTS, INC. | |
49 | 00840113230884 | 713600 | Intended to support and maintain the position of an anesthetized patient during surgery | Leg Comfort Pad | ASPEN SURGICAL PRODUCTS, INC. | |
50 | 00840113230877 | 713500 | Intended to support and maintain the position of an anesthetized patient during surgery | Thigh Holder Pad | ASPEN SURGICAL PRODUCTS, INC. |