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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-125SOLID145
In Commercial Distribution

  • 10852528005244 ()

  • Crown Type, Solid
  • Intro Sheath 4 Fr
  • Max OD 0.052 inches
  • High Speed 120 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire size OD 0.014 inches
  • Shaft Length 145 cm
  • Nose Length 7 mm
  • Crown Diameter 1.25 mm
7-10012

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-150SOLID145
In Commercial Distribution

  • 10852528005237 ()

  • Crown Type, Solid
  • Intro Sheath 5 Fr
  • Max OD 0.063 inches
  • High Speed 120 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire Size OD 0.014 inches
  • Shaft Length 145 cm
  • Nose Length 10 mm
  • Crown Diameter 1.50 mm
7-10011

  • Mechanical atherectomy system catheter, peripheral
VIPERWIRE, ADVANCED, .012" DIA .012" SPRING TIP, 200CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-200
In Commercial Distribution

  • 30852528005224 ()
  • 10852528005220 ()

  • Length: 200 Centimeter
  • Max Shaft Diameter 0.012 inches
  • Max Tip Diameter 0.014 inches
7-10004

  • Peripheral vascular guidewire, manual
DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.25MM, 60CM SHAFT
Cardiovascular Systems, Inc.
DBP-125SOLID60
In Commercial Distribution

  • 10852528005213 ()

  • Intro Sheath 4 Fr
  • Max OD 0.053 inches
  • High Speed 140 krpm
  • Medium Speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.012 inches
  • Shaft Length 60 cm
  • Nose Length 10 mm
  • Crown Diameter 1.25 mm
  • Crown Type, Solid
7-10002

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 60CM SHAFT
Cardiovascular Systems, Inc.
DBP-125MICRO60
In Commercial Distribution

  • 10852528005206 ()

  • Intro Sheath 4 Fr
  • Max OD 0.053 inches
  • High Speed 140 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • guidewire size OD 0.012 inches
  • Shaft Length 60 cm
  • Nose Length 7 mm
  • Crown Size 1.25 mm
  • Crown Type, Micro
7-10001

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-125MICRO145
Not in Commercial Distribution

  • 10852528005190 ()

  • Crown Type, Micro
  • Intro Sheath 4 Fr
  • Max OD 0.052 inches
  • High Speed 140 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire Size OD 0.014 inches
  • Shaft Length 145 cm
  • Nose Length 7 mm
  • Crown Diameter 1.25 mm
DBP-125MICRO145

  • Mechanical atherectomy system catheter, peripheral
Guidewire, Viperwire Adavnce Coronary Floppy, .012: dia, .014" Spring Tip, 1 Pack 325 cm
Cardiovascular Systems, Inc.
GWC-12325LG-FLP
In Commercial Distribution

  • 30852528005187 ()
  • 10852528005183 ()

  • Length; 325cm
  • Max Shaft Diameter; 0.012 inches
  • Max Tip Diameter; 0.014 inches
72010-01

  • Cardiac/peripheral vascular guidewire, single-use
CORONARY ELECTRIC, CLASSIC CROWN, 1.50MM
Cardiovascular Systems, Inc.
DBEC-150
In Commercial Distribution

  • 10852528005176 ()

  • Intro Sheath; 6Fr
  • Max OD; 0.061 inches
  • High speed; 120krpm
  • Low speed; 80krpm
  • Guidewire size OD; 0.012 inches
  • Shaft length; 135cm
  • Nose length; 10mm
  • Crown diameter; 1.5mm
  • Crown Type, Classic
70058-03

  • Mechanical atherectomy system, coronary, line-powered
SALINE INFUSION PUMP (SIP)
Cardiovascular Systems, Inc.
SIP-3000
In Commercial Distribution

  • 10852528005138 ()
70057-03

  • Atherectomy system saline/lubricant pump
VIPERTRACK, 20 PACK
Cardiovascular Systems, Inc.
VPRTRKMM20
In Commercial Distribution

  • 30852528005118 ()
  • 10852528005114 ()

  • Length: 500 Millimeter
72029-01

  • X-ray film ruler
VIPERTRACK, 50 PACK
Cardiovascular Systems, Inc.
VPR-TRK
In Commercial Distribution

  • 30852528005101 ()
  • 10852528005107 ()

  • Length: 30 Centimeter
72014-02

  • X-ray film ruler
VIPERTRACK, 20 PACK
Cardiovascular Systems, Inc.
VPR-TRK 20
In Commercial Distribution

  • 10852528005091 ()
  • 30852528005095 ()

  • Length: 30 Centimeter
72014-01

  • X-ray film ruler
VIPERWIRE, ADVANCE PERIPHERAL, .017" DIA SPRING TIP, 335CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-17
In Commercial Distribution

  • 30852528005088 ()
  • 10852528005084 ()

  • Length: 335 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.017 inches
72023-02

  • Peripheral vascular guidewire, manual
VIPERWIRE, ADVANCE PERIPHERAL, .014" DIA SPRING TIP, 335CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-14
In Commercial Distribution

  • 30852528005071 ()
  • 10852528005077 ()

  • Length: 335 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.014 inches
72023-01

  • Peripheral vascular guidewire, manual
STEALTH, SOLID MICRO, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-125S
In Commercial Distribution

  • 10852528005060 ()

  • Crown Type, Solid Micro
  • Intro Sheath 6Fr
  • Max OD 0.070 inches
  • high speed 120 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire OD 0.014 inches
  • shaft length 145 cm
  • nose length 10 mm
  • Crown Diameter 1.25 mm
70056-11

  • Mechanical atherectomy system catheter, peripheral
STEALTH, SOLID, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-200
In Commercial Distribution

  • 10852528005053 ()

  • Intro Sheath 6 Fr
  • Max OD 0.079 inches
  • high speed 120 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.014 inches
  • shaft length 145 cm
  • Nose Length 30 mm
  • Crown Diameter 2.00 mm
  • Crown Type, Solid
70056-06

  • Mechanical atherectomy system catheter, peripheral
STEALTH, SOLID, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-150
In Commercial Distribution

  • 10852528005046 ()

  • Intro Sheath 6 Fr
  • max OD 0.070 inches
  • high speed 120 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.014 inches
  • shaft length 145 cm
  • nose length 10 mm
  • Crown diameter 1.50 mm
  • Crown Type, Solid
70056-04

  • Mechanical atherectomy system catheter, peripheral
STEALTH, SOLID, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-125
In Commercial Distribution

  • 10852528005039 ()

  • Intro Sheath 6 Fr
  • Max OD 0.070 inches
  • high speed 120 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.014 inches
  • shaft length 145 cm
  • Nose Length 10 mm
  • Crown Diameter 1.25 mm
  • Crown Type, Solid
70056-03

  • Mechanical atherectomy system catheter, peripheral
STEALTH, CLASSIC, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBE-200
In Commercial Distribution

  • 10852528005022 ()

  • Intro Sheath 6 Fr
  • Max OD 0.079 inches
  • high speed 140 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.014 inches
  • shaft length 145 cm
  • nose length 20 mm
  • Crown Diameter 2.00 mm
  • Crown Type, Classic
70056-02

  • Mechanical atherectomy system catheter, peripheral
Evaluation Pack - Airo™ CPAP Mask Liners - Box of 25 - Small
Athfar 828 Inc
EVAL-AS-25
In Commercial Distribution

  • 00850054813312 ()
  • 10850054813319 ()
EVAL-AS-25

  • General-purpose medical fibre padding
Evaluation Pack - Airo™ CPAP Mask Liners - Box of 25 - Medium
Athfar 828 Inc
EVAL-AM-25
In Commercial Distribution

  • 00850054813305 ()
  • 10850054813302 ()
EVAL-AM-25

  • General-purpose medical fibre padding
Evaluation Pack - Airo™ CPAP Mask Liners - Box of 25 - Large
Athfar 828 Inc
EVAL-AL-25
In Commercial Distribution

  • 00850054813299 ()
  • 10850054813296 ()
EVAL-AL-25

  • General-purpose medical fibre padding
Sample - Airo™ CPAP Mask Liners - Box of 100 - Large
Athfar 828 Inc
SMPL-AL-100
In Commercial Distribution

  • 00850054813282 ()
  • 10850054813289 ()


  • General-purpose medical fibre padding
Sample - Airo™ CPAP Mask Liners - Box of 100 - Medium
Athfar 828 Inc
SMPL-AM-100
In Commercial Distribution

  • 00850054813244 ()
  • 10850054813241 ()


  • General-purpose medical fibre padding
Sample - Airo™ CPAP Mask Liners - Box of 100 - Small
Athfar 828 Inc
SMPL-AS-100
In Commercial Distribution

  • 00850054813206 ()
  • 10850054813203 ()


  • General-purpose medical fibre padding
Sample - Airo™ CPAP Mask Liners - Box of 100 - Large
Athfar 828 Inc
SMPL-AL-100
Not in Commercial Distribution

  • 00850054813114 ()
  • 10850054813111 ()
SMPL-AL-100

  • General-purpose medical fibre padding
Sample - Airo™ CPAP Mask Liners - Box of 100 - Medium
Athfar 828 Inc
SMPL-AM-100
Not in Commercial Distribution

  • 00850054813107 ()
  • 10850054813104 ()
SMPL-AM-100

  • General-purpose medical fibre padding
Sample - Airo™ CPAP Mask Liners - Box of 100 - Small
Athfar 828 Inc
SMPL-AS-100
Not in Commercial Distribution

  • 00850054813091 ()
  • 10850054813098 ()
SMPL-AS-100

  • General-purpose medical fibre padding
Custom Ti Base Engaging GM H 4.0
IMPLANT PROTESIS DENTAL 2004 SL
INC3D
In Commercial Distribution

  • 08435566630194 ()
IPD/RB-IR-06/3D

  • Dental implant suprastructure, permanent, preformed
Open Tray Coping Screw Ø 3.0
IMPLANT PROTESIS DENTAL 2004 SL
TTI
In Commercial Distribution

  • 08435566630101 ()
IPD/EA-TN-00/C

  • Dental prosthesis/implant abutment screw analog, reusable
Temporary abutment Non-Engaging Ø 3,0
IMPLANT PROTESIS DENTAL 2004 SL
PP
In Commercial Distribution

  • 08435566630026 ()
IPD/AD-PT-07

  • Dental implant suprastructure, temporary, preformed, single-use
Temporary abutment Engaging Ø 3,0
IMPLANT PROTESIS DENTAL 2004 SL
PP
In Commercial Distribution

  • 08435566630019 ()
IPD/AD-PT-06

  • Dental implant suprastructure, temporary, preformed, single-use
PSD abutment holder
IMPLANT PROTESIS DENTAL 2004 SL
LL
In Commercial Distribution

  • 08435566630002 ()
IPD/KA-CL-14

  • Surgical screwdriver, reusable
Scan transfer Open Tray Coping Screw Ø 4,8
IMPLANT PROTESIS DENTAL 2004 SL
TTI
In Commercial Distribution

  • 08435566629976 ()
IPD/AB-TR-11/C

  • Dental prosthesis/implant abutment screw analog, reusable
Stump Die 3D
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
Not in Commercial Distribution

  • 08435566629969 ()
IPD/KA-AN-01/3D

  • Dental implant analog
Healing abutment Ti Ø 5,1 h 3 mm
IMPLANT PROTESIS DENTAL 2004 SL
TC
In Commercial Distribution

  • 08435566629938 ()
IPD/AA-DW-03

  • Dental implant suprastructure, temporary, preformed, single-use
Scan Transfer Multi-unit Ø 4,8
IMPLANT PROTESIS DENTAL 2004 SL
SCTR
In Commercial Distribution

  • 08435566629747 ()
IPD/AB-SR-11

  • Dental prosthesis/implant abutment screw analog, reusable
Open Tray Coping Screw Ø 3.3 Ø 3.8 Ø 4.3
IMPLANT PROTESIS DENTAL 2004 SL
TTI
In Commercial Distribution

  • 08435566629709 ()
IPD/JB-TR-00/C

  • Dental prosthesis/implant abutment screw analog, reusable
Digital analog Ø 3.8
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566628986 ()
IPD/JB-AR-00/3D

  • Dental implant analog
Digital analog Ø 3.3
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566628627 ()
IPD/JB-AN-00/3D

  • Dental implant analog
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