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No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 10194717105756 AN01041E OKE Port Introducer Kit 2 Regard™
2 10194717105749 HT01040D OEQ Angiography/Angioplasty Kit 2 Regard™
3 10194717105466 OR01009C OJH Orthopedic Tray 1 Regard™
4 10194717105077 GS00817F LRO General Surgery Tray 2 Regard™
5 10194717102236 GS00441P LRO General Surgery Tray 2 Regard™
6 10194717102205 GS00403H OHD Gynecological Laparoscopic Kit 2 Regard™
7 10194717100300 HT00271F OES Cardiac Catheterization Kit 2 Regard™
8 10194717104025 HT00235L OES Cardiac Catheterization Kit 2 Regard™
9 10194717106852 LD00044O MLS Labor And Delivery Kit 2 Regardo™
10 10194717116059 NU00260K Spine Pack OJH Orthopedic Tray 1 Regard
11 10194717115977 NU00303J Cervical OJG Neurological Tray 1 Regard
12 10194717115960 NU00260J Spine Pack OJH Orthopedic Tray 1 Regard
13 10194717115939 OR00258I Minor Ortho OJH Orthopedic Tray 1 Regard
14 10194717115427 NU00303I Cervical OJG Neurological Tray 1 Regard
15 10194717115403 NU00260I Spine Pack OJH Orthopedic Tray 1 Regard
16 10194717115380 NU00263Q Craniotomy OJG Neurological Tray 1 Regard
17 10194717114031 GS00823E STEREOTACTIC KIT LRO General Surgery Tray 2 Regard
18 10194717108948 CV00966B Open Heart Supply OEZ Cardiovascular Procedure Kit 2 Regard
19 10194717108931 OR01092A Hip Arthroscopy OJH Orthopedic Tray 1 Regard
20 10194717108924 AN01084D Anesthesia Bundle OGD Custom Anesthesia Tray 2 Regard
21 10194717108917 OR00769J CCOR Hand OJH Orthopedic Tray 1 Regard
22 10194717108900 GS00823D Stereotactic LRO General Surgery Tray 2 Regard
23 10194717108894 HT00468H Pacemaker OES Cardiac Catheterization Kit 2 Regard
24 10194717108887 UR00098S Cysto LRO General Surgery Tray 2 Regard
25 10194717108870 NU00263P Craniotomy OJG Neurological Tray 1 Regard
26 10194717108863 NU00303H Cervical OJG Neurological Tray 1 Regard
27 10194717108856 OR00258H Minor Ortho OJH Orthopedic Tray Regard
28 10194717108849 NU00260H Spine Pack OJH Orthopedic Tray 1 Regard
29 10194717108832 GS00401B Isolation Kit PXC Personal Protection Kit 1 Regard
30 10194717108825 NU00010X LAMINECTOMY OJG Neurological Tray 1 Regard
31 10194717108788 LD00427L C-Section OHM Cesarean Section Tray 2 Regard
32 10194717108771 OB00100Y C-Section OHM Cesarean Section Tray 2 Regard
33 10194717108764 OR00344J Knee Artho OJH Orthopedic Tray 1 Regard
34 10194717108757 OR00346K Total Knee OJH Orthopedic Tray 1 Regard
35 10194717108733 CV01003H CV 2 A&B OEZ Cardiovascular Procedure Kit 2 Regard
36 10194717108726 NU00962C Laminectomy OJG Neurological Tray 1 Regard
37 10194717108719 GY00958E GYN/LAPAROSCOPY OHD Gynecological Laparoscopic Kit 2 Regard
38 10194717108689 Or00734K Total Knee OJH Orthopedic Tray 1 Regard
39 10194717108641 CV00364F Shuntagram OEQ Angiography/Angioplasty Kit 2 Regard
40 10194717100041 OR00240M OJH Orthopedic Tray 1 Regard™
41 10194717108412 OR00342L OJH Orthopedic Tray 1 Regard™
42 10194717106838 OR00107AE OJH Orthopedic Tray 1 Regard™
43 10194717105695 GU01035B FDE Laparoscopy Kit 2 Regard™
44 10194717105688 OR01034B OJH Orthopedic Tray 1 Regard™
45 10194717105671 OR01033C OJH Orthopedic Tray 1 Regard™
46 10194717105664 GS01032B LRO General Surgery Tray 2 Regard™
47 10194717105657 GS01031C FDE Laparoscopy Kit 2 Regard™
48 10194717105640 ET01030B OGR Ear, Nose, And Throat Surgical Tray 1 Regard™
49 10194717105633 OR01029C OJH Orthopedic Tray 1 Regard™
50 10194717105367 GS00996A LRO General Surgery Tray 2 Regard™
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22 00191072177971 BHTR60P TRAUMA ACS AMERICAN CONTRACT SYSTEMS, INC.
23 00191072177940 BHTA02L TAMPONADE ACS AMERICAN CONTRACT SYSTEMS, INC.
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