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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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Healing abutment GM H 7.0
IMPLANT PROTESIS DENTAL 2004 SL
TC
In Commercial Distribution

  • 08435566630231 ()
IPD/RB-DR-07

  • Dental implant suprastructure, temporary, preformed, single-use
Straight Multi-unit GM H 4.5
IMPLANT PROTESIS DENTAL 2004 SL
PMR
In Commercial Distribution

  • 08435566630217 ()
IPD/RB-MR-04

  • Dental implant suprastructure, permanent, preformed
No Description
SMART MEDICAL DEVICE Co., Ltd.
DM-VME03s
Not in Commercial Distribution

  • 00193026000007 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Diamondback Peripheral, Exchangeable Series, Cartridge, 2.00 Solid, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-200SOL145
In Commercial Distribution

  • 10852528005954 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.079 inches
  • Crown Type: Solid
  • High Speed: 120 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145 cm
  • Nose Length: 30 mm
  • Crown Diameter: 2.00 mm
7-10031-04

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, Cartridge, 1.25 Solid, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-125SOL145
In Commercial Distribution

  • 10852528005930 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown Type: Solid
  • High Speed: 120 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145 cm
  • Nose Length: 7 mm
  • Crown Diameter: 1.25 mm
7-10031-02

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, 2.00 Classic, 145 cm shaft
Cardiovascular Systems, Inc.
DBP–EX-200CLA145
In Commercial Distribution

  • 10852528005916 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.079 inches
  • Crown Type: Classic
  • High Speed: 140 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145 cm
  • Nose Length: 20 mm
  • Crown Diameter: 2.00 mm
7-10030-11

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

  • 10852528005800 ()
7-10037-07

  • Atherectomy system saline/lubricant pump
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
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
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
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
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