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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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Straight Multi-unit Ø 3.4 H 2.0
IMPLANT PROTESIS DENTAL 2004 SL
PMR
In Commercial Distribution

  • 08435566630330 ()
IPD/BB-MN-02

  • Dental implant suprastructure, permanent, preformed
Straight Multi-unit Ø 3.4 H 1.0
IMPLANT PROTESIS DENTAL 2004 SL
PMR
In Commercial Distribution

  • 08435566630323 ()
IPD/BB-MN-01

  • Dental implant suprastructure, permanent, preformed
Straight Multi-unit Ø 3.5 H 3.0
IMPLANT PROTESIS DENTAL 2004 SL
PMR
In Commercial Distribution

  • 08435566630262 ()
IPD/AA-MN-03

  • Dental implant suprastructure, permanent, preformed
Straight Multi-unit Ø 3.5 H 2.0
IMPLANT PROTESIS DENTAL 2004 SL
PMR
In Commercial Distribution

  • 08435566630255 ()
IPD/AA-MN-02

  • Dental implant suprastructure, permanent, preformed
Straight Multi-unit Ø 3.5 H 1.0
IMPLANT PROTESIS DENTAL 2004 SL
PMR
In Commercial Distribution

  • 08435566630248 ()
IPD/AA-MN-01

  • Dental implant suprastructure, permanent, preformed
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
FLOTEC INC
RW Regulator
In Commercial Distribution

  • B741RW0 ()


  • Non-fixed medical gas cylinder regulator
No Description
FLOTEC INC
Mass Casualty Assembly
In Commercial Distribution

  • B741MC0 ()


  • High-pressure medical gas hose
  • Medical gas flowmeter, dial-type
  • Non-fixed medical gas cylinder regulator
No Description
FLOTEC INC
Flowmeter
In Commercial Distribution

  • B741FM0 ()


  • Medical gas flowmeter, dial-type
No Description
FLOTEC INC
InGage Regulator
In Commercial Distribution

  • B741DL0 ()


  • Non-fixed medical gas cylinder regulator
No Description
SMART MEDICAL DEVICE Co., Ltd.
DM-VME03s
Not in Commercial Distribution

  • 00193026000007 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
The G5 Vibracare ZX1 Percussor is our durable, hand-held percussor used in respiratory therapy applications. Totally self-contained, and weighing less than three pounds, it provides optimal freedom of movement and portability with a ten foot hospital grade power cord. This model may be used with a variety of applicators and has a continuously-variable speed range of 20 - 50 cycles per second. This combination of applicators and speeds provides for a highly-versatile treatment range. It is the only hand-held percussor/massager to be granted C.S.A's highest medical operational rating. Comes with applicators 212, 216, 229, 230.
GENERAL PHYSIOTHERAPY INC
VIBRACARE ZX1
In Commercial Distribution

  • 00007469820231 ()

  • Weight: 6 Pound
VIBRACARE ZX1

  • Hand-held electric massager
The MGB Alert Internal Control Set IC2 consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2 can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes.
Elitechgroup Mdx LLC
800362
In Commercial Distribution

  • 03661540951411 ()
800362

  • Exogenous DNA/RNA internal control IVD, kit
Endovenous Radiofrequency Ablation (RFA) Catheter 7-60
Vein360 LLC
VEN-7-60
Not in Commercial Distribution

  • 08600360005107 ()
VEN-7-60

  • Radio-frequency ablation system
Endovenous Radiofrequency Ablation (RFA) Catheter 3-60
Vein360 LLC
VEN-3-60
Not in Commercial Distribution

  • 08600360005022 ()
VEN-3-60

  • Radio-frequency ablation system
Endovenous Radiofrequency Ablation (RFA) Catheter 7-100
Vein360 LLC
VEN-7-100
Not in Commercial Distribution

  • 08600360005008 ()
VEN-7-100

  • Radio-frequency ablation system
DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM
Cardiovascular Systems, Inc.
DBEC-125
In Commercial Distribution

  • 10852528005169 ()

  • Intro Sheath; 6 french
  • Max OD; 0.057 inches
  • High speed; 120 krpm
  • low speed; 80 krpm
  • Guidewire size OD; 0.012 inches
  • Shaft Length; 135 cm
  • Nose Length; 5mm
  • Crown Size; 1.25 mm
  • Crown Type, Classic
70058-02

  • Mechanical atherectomy system, coronary, line-powered
VIPERSLIDE, 100ML BAG, 10 PK
Cardiovascular Systems, Inc.
VPR-SLD2
In Commercial Distribution

  • 30852528005125 ()
  • 10852528005121 ()
72031-01

  • Atherectomy system lubricant
STEALTH, CLASSIC, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBE-150
In Commercial Distribution

  • 10852528005015 ()

  • Intro Sheath 6 Fr
  • Max OD 0.070 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 15 mm
  • Crown diameter 1.50 mm
  • Crown Type, Classic
70056-01

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, Cartridge, 1.25 Micro, 75 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-125MIC75
In Commercial Distribution

  • 10852528005961 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown Type: Micro
  • High Speed: 140 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 75 cm
  • Nose Length: 7 mm
  • Crown diameter: 1.25 mm
7-10031-05

  • Mechanical atherectomy system catheter, peripheral
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, 1.50 Solid, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-150SOL145
In Commercial Distribution

  • 10852528005947 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 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: 10 mm
  • Crown Diameter: 1.50 mm
7-10031-03

  • 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, Cartridge, 1.25 Micro, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-125MIC145
In Commercial Distribution

  • 10852528005923 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown Type: Micro
  • High Speed: 140 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
7-10031-01

  • 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
STEALTH, SOLID, 2.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-225
In Commercial Distribution

  • 10852528005343 ()

  • 7 Fr Intro sheath
  • 0.089 inches Max OD
  • Solid Crown type
  • 120 krpm High speed
  • 90 krpm Medium speed
  • 60 krpm Low speed
  • 0.014 inches Guidewire size OD
  • 145 cm Shaft Length
  • 30 mm Nose length
  • 2.25 mm Crown diameter
70056-07

  • Mechanical atherectomy system catheter, peripheral
VIPERWIRE, ADVANCE FLEXTIP PERIPHERAL, .014" DIA SPRING TIP, 335CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-FT18
In Commercial Distribution

  • 30852528005323 ()
  • 10852528005329 ()

  • Length: 335 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.018 inches
7-10026-02

  • Peripheral vascular guidewire, manual
VIPERWIRE, ADVANCE FLEXTIP PERIPHERAL, .018" DIA SPRING TIP, 335CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-FT14
In Commercial Distribution

  • 30852528005316 ()
  • 10852528005312 ()

  • Length: 335 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.014 inches
7-10026-01

  • Peripheral vascular guidewire, manual
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