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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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Stealth - 10852528005022

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

Stealth - 10852528005015

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

Airo™ CPAP Mask Liners - 10850054813319

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

Airo™ CPAP Mask Liners - 10850054813302

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

Airo™ CPAP Mask Liners - 10850054813296

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

Airo™ CPAP Mask Liners - 10850054813289

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

Airo™ CPAP Mask Liners - 10850054813241

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

Airo™ CPAP Mask Liners - 10850054813203

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

Airo™ CPAP Mask Liners - 10850054813111

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

Airo™ CPAP Mask Liners - 10850054813104

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

Airo™ CPAP Mask Liners - 10850054813098

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

Fifty50 Sport - 00892896000260

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

Fifty50 - 00892896000093

Fifty50 Blood Glucose Test Strip
i-SENS, Inc.
163604
In Commercial Distribution

  • 20892896000097 ()
  • 10892896000090 ()
  • 00892896000093 ()
  • 50892896000098 ()


  • Glucose IVD, reagent

Fifty50 - 00892896000086

Fifty50 Blood Glucose Monitoring System 2.0
i-SENS, Inc.
163308-302
In Commercial Distribution

  • 10892896000083 ()
  • 00892896000086 ()


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

Fifty50 - 00892896000017

Fifty50 Blood Glucose Test Strip
i-SENS, Inc.
163140
In Commercial Distribution

  • 20892896000011 ()
  • 10892896000014 ()
  • 00892896000017 ()
  • 50892896000012 ()


  • Glucose IVD, reagent

IPD - 08435566641374

Digital analog RP Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641374 ()
IPD/YB-AR-90/3D

  • Dental implant analog

IPD - 08435566641367

Digital analog RP Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641367 ()
IPD/XA-AR-90/3D

  • Dental implant analog

IPD - 08435566641350

Digital analog Ø 4,0 Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641350 ()
IPD/WB-AR-90/3D

  • Dental implant analog

IPD - 08435566641343

Digital analog RP Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641343 ()
IPD/WA-AR-90/3D

  • Dental implant analog

IPD - 08435566641336

Digital analog RP Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641336 ()
IPD/UB-AR-90/3D

  • Dental implant analog

IPD - 08435566641329

Digital analog NP Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641329 ()
IPD/UB-AN-90/3D

  • Dental implant analog

IPD - 08435566641312

Digital analog Standard 3.5 Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641312 ()
IPD/TB-AR-90/3D

  • Dental implant analog

IPD - 08435566641305

Digital analog Ø 3,3 Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641305 ()
IPD/TA-AT-90/3D

  • Dental implant analog

IPD - 08435566641299

Digital analog Ø 4,5 Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641299 ()
IPD/SB-AW-90/3D

  • Dental implant analog

IPD - 08435566641282

Digital analog Ø 4,1 Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641282 ()
IPD/SB-AR-90/3D

  • Dental implant analog

IPD - 08435566641275

Digital analog Ø 3,25 Ø 3,75 Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641275 ()
IPD/SB-AN-90/3D

  • Dental implant analog

IPD - 08435566641268

Digital analog Ø 3,5 Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641268 ()
IPD/RD-AN-90/3D

  • Dental implant analog

IPD - 08435566641251

Digital analog RP Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641251 ()
IPD/RC-AR-90/3D

  • Dental implant analog

IPD - 08435566641244

Digital analog GM Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641244 ()
IPD/RB-AR-90/3D

  • Dental implant analog

IPD - 08435566641237

Digital analog Ø 5,0 Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641237 ()
IPD/RA-AW-90/3D

  • Dental implant analog

IPD - 08435566641220

Digital analog Ø 3,3 Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641220 ()
IPD/RA-AN-90/3D

  • Dental implant analog

IPD - 08435566641213

Digital analog RP Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641213 ()
IPD/QB-AR-90/3D

  • Dental implant analog

IPD - 08435566641206

Digital analog PSD Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641206 ()
IPD/PS-AR-90/3D

  • Dental implant analog

IPD - 08435566641190

Digital analog Ø 4,0 Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641190 ()
IPD/OB-AR-90/3D

  • Dental implant analog

IPD - 08435566641183

Digital analog Ø 3,5 Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641183 ()
IPD/OB-AN-90/3D

  • Dental implant analog

IPD - 08435566641176

Digital analog S5 Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641176 ()
IPD/NA-AW-90/3D

  • Dental implant analog

IPD - 08435566641169

Digital analog S2 Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641169 ()
IPD/NA-AN-90/3D

  • Dental implant analog

IPD - 08435566641152

Digital analog Ø 3,3 Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641152 ()
IPD/MB-AT-90/3D

  • Dental implant analog

IPD - 08435566641145

Digital analog Ø 4,25 Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641145 ()
IPD/MB-AR-90/3D

  • Dental implant analog

IPD - 08435566641138

Digital analog Ø 3,8 Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641138 ()
IPD/MB-AN-90/3D

  • Dental implant analog
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