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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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STERIZONE® CI+ Chemical indicator - 00690455438109

The STERIZONE® CI+ Chemical Indicator (CI+) is a Type 1 (Class 1) process indicator, which distinguishes between processed and unprocessed medical device packages, intended for sterilization using the STERIZONE® VP4 Sterilizer.
TSO3 Inc
43810-1
In Commercial Distribution

  • 00690455438109 ()
  • 00690455438116 ()
43810-1

  • Chemical/physical sterilization process indicator

STERIZONE® BI+ Self-contained Biological Indicator - 00690455426021

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

SurePass CTR NS Blade - 00860011634836

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 - 00850054813381

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 - 00850054813374

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 - 00850054813367

Airo™ CPAP Mask Liners - Box of 25 - Medium
Athfar 828 Inc
AM-25
In Commercial Distribution

  • 00850054813336 ()
  • 00850054813367 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813329

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 - 00850054813084

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 - 00850054813077

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 - 00850054813060

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 - 00850054813053

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 - 00850054813046

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 - 00850054813022

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 - 00850054813008

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

LUMINELLE DTx Hysteroscopy System - 00853277008046

Hysteroscopy System indicated for both Hysteroscopy and Cystoscopy to permit direct viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
UVISION 360, INC.
LumDTX-A
In Commercial Distribution

  • 00853277008046 ()
20030

  • Flexible video cystoscope, reusable
  • Endoscope sheath, single-use
  • Flexible fibreoptic hysteroscope

Endovenous Radiofrequency Ablation (RFA) Catheter - 08600360005107

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 - 08600360005022

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 - 08600360005008

Endovenous Radiofrequency Ablation (RFA) Catheter 7-100
Vein360 LLC
VEN-7-100
Not in Commercial Distribution

  • 08600360005008 ()
VEN-7-100

  • Radio-frequency ablation system

MGB Alert Internal Control Set IC2-480 rxn - 03661540951411

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

IPD - 08435566641428

Digital analog Ø 4,8 Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641428 ()
IPD/EB-AW-90/3D

  • Dental implant analog

IPD - 08435566641411

Digital analog Ø 3,0 Full set
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566641411 ()
IPD/EB-AT-90/3D

  • Dental implant analog

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
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