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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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The STERIZONE® BI+ Self-contained Biological Indicator (SCBI) (Figure 1) is a self-contained stand-alone biological monitor intended to provide users with a means to assess spore kill by the vaporized 125-280 Solution™ (50 wt% hydrogen peroxide) injected in the STERIZONE® VP4 Sterilizer.
TSO3 Inc
42602-1
In Commercial Distribution

  • 00690455426021 ()
  • 00690455750218 ()
42602-1

  • Biological sterilization indicator
Carpal Tunnel Release, (1) SurePass CTR Non-Sterile Blade
Dev4
CT-2003NS
In Commercial Distribution

  • 00860011634836 ()
  • 10860011634833 ()


  • Manual scalpel blade, reusable
Airo™ CPAP Mask Liners - Box of 25 - Large
Athfar 828 Inc
AL-25
In Commercial Distribution

  • 00850054813343 ()
  • 00850054813381 ()


  • General-purpose medical fibre padding
Airo™ CPAP Mask Liners - Box of 25 - Small
Athfar 828 Inc
AS-25
In Commercial Distribution

  • 00850054813350 ()
  • 00850054813374 ()


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

  • 00850054813336 ()
  • 00850054813367 ()


  • General-purpose medical fibre padding
Evaluation Pack - Airo™ CPAP Mask Liners - Box of 50 - Large
Athfar 828 Inc
EVAL-AL-50
In Commercial Distribution

  • 00850054813299 ()
  • 00850054813329 ()
EVAL-AL-50

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

  • 00850054813350 ()
  • 00850054813084 ()


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

  • 00850054813336 ()
  • 00850054813077 ()


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

  • 00850054813343 ()
  • 00850054813060 ()


  • General-purpose medical fibre padding
Airo™ CPAP Mask Liners - Box of 50 - Small
Athfar 828 Inc
AS-50
In Commercial Distribution

  • 00850054813350 ()
  • 00850054813053 ()


  • General-purpose medical fibre padding
Airo™ CPAP Mask Liners - Box of 50 - Medium
Athfar 828 Inc
AM-50
In Commercial Distribution

  • 00850054813336 ()
  • 00850054813046 ()


  • General-purpose medical fibre padding
Airo™ CPAP Mask Liners - Box of 50 - Large
Athfar 828 Inc
AL-50
In Commercial Distribution

  • 00850054813343 ()
  • 00850054813022 ()


  • General-purpose medical fibre padding
Airo™ CPAP Mask Liners - Box of 25 - Small
Athfar 828 Inc
AS-25
Not in Commercial Distribution

  • 00850054813121 ()
  • 00850054813008 ()
AS-25

  • General-purpose medical fibre padding
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
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
Fifty50 Sport Blood Glucose Monitoring System 2.0
i-SENS, Inc.
163424-201
In Commercial Distribution

  • 00892896000260 ()
  • 10892896000267 ()


  • Home-use/point-of-care blood glucose monitoring system IVD
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