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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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Arthrorazor - 00860012754823

No Description
Orthodoxo LLC
2077.01304
In Commercial Distribution

  • 00860012754823 ()


  • Arthroscopic shaver system blade, single-use

Arthrorazor - 00860012754816

No Description
Orthodoxo LLC
2077.01302
In Commercial Distribution

  • 00860012754816 ()


  • Arthroscopic shaver system blade, single-use

Arthrorazor - 00860012754809

No Description
Orthodoxo LLC
2077.01251
In Commercial Distribution

  • 00860012754809 ()


  • Arthroscopic shaver system blade, single-use

Bioemmalab - 00860012750504

4x4 Silicone Foam Dressing
NUTRIARTMIS INC
50504
In Commercial Distribution

  • 00860012750504 ()
  • 00860012750566 ()


  • Wound-nonadherent dressing, absorbent, antimicrobial

Porges Coloplast - 05708932705394

ImaJin™ Double loop ureteral stent silicone hydro-coated open/open CH FR 08 length 28 cm with steerable pusher
Coloplast A/S
BCHJ85
In Commercial Distribution

  • 05708932705400 ()
  • 05708932705394 ()

  • Catheter Gauge: 8 French
  • Length: 28 Centimeter
BCHJ85

  • Polymeric ureteral stent

Porges Coloplast - 05708932705363

ImaJin™ Double loop ureteral stent silicone hydro-coated open/open CH FR 08 length 26 cm with steerable pusher
Coloplast A/S
BCHJ84
In Commercial Distribution

  • 05708932705370 ()
  • 05708932705363 ()

  • Length: 26 Centimeter
  • Catheter Gauge: 8 French
BCHJ84

  • Polymeric ureteral stent

Porges Coloplast - 05708932705332

ImaJin™ Double loop ureteral stent silicone hydro-coated open/open CH FR 08 length 24 cm with steerable pusher
Coloplast A/S
BCHJ83
In Commercial Distribution

  • 05708932705349 ()
  • 05708932705332 ()

  • Length: 24 Centimeter
  • Catheter Gauge: 8 French
BCHJ83

  • Polymeric ureteral stent

Porges Coloplast - 05708932705271

ImaJin™ Double loop ureteral stent silicone hydro-coated open/open CH FR 08 length 16 cm with steerable pusher
Coloplast A/S
BCHJ81
In Commercial Distribution

  • 05708932705288 ()
  • 05708932705271 ()

  • Length: 16 Centimeter
  • Catheter Gauge: 8 French
BCHJ81

  • Polymeric ureteral stent

Porges Coloplast - 05708932705240

ImaJin™ Double loop ureteral stent silicone hydro-coated open/open CH FR 07 length 30 cm with steerable pusher
Coloplast A/S
BCHJ76
In Commercial Distribution

  • 05708932705257 ()
  • 05708932705240 ()

  • Length: 30 Centimeter
  • Catheter Gauge: 7 French
BCHJ76

  • Polymeric ureteral stent

Simple Solutions Medical - 00860012609376

Lung Isolation (Emergency Airway) Convenience Kit - Right - 39 Fr
SIMPLE SOLUTIONS MEDICAL
LIT-39-R
In Commercial Distribution

  • 00860012609376 ()


  • Endobronchial tube

Porges Coloplast - 05708932705189

ImaJin™ Double loop ureteral stent silicone hydro-coated open/open CH FR 07 length 26 cm with steerable pusher
Coloplast A/S
BCHJ74
In Commercial Distribution

  • 05708932705196 ()
  • 05708932705189 ()

  • Catheter Gauge: 7 French
  • Length: 26 Centimeter
BCHJ74

  • Polymeric ureteral stent

Porges Coloplast - 05708932705158

ImaJin™ Double loop ureteral stent silicone hydro-coated open/open CH FR 07 length 24 cm with steerable pusher
Coloplast A/S
BCHJ73
In Commercial Distribution

  • 05708932705165 ()
  • 05708932705158 ()

  • Catheter Gauge: 7 French
  • Length: 24 Centimeter
BCHJ73

  • Polymeric ureteral stent

Porges Coloplast - 05708932705127

ImaJin™ Double loop ureteral stent silicone hydro-coated open/open CH FR 07 length 22 cm with steerable pusher
Coloplast A/S
BCHJ77
In Commercial Distribution

  • 05708932705134 ()
  • 05708932705127 ()

  • Length: 22 Centimeter
  • Catheter Gauge: 7 French
BCHJ77

  • Polymeric ureteral stent

Simple Solutions Medical - 00860012609321

Lung Isolation (Emergency Airway) Convenience Kit - Left - 28 Fr
SIMPLE SOLUTIONS MEDICAL
LIT-28-L
In Commercial Distribution

  • 00860012609321 ()


  • Endobronchial tube

Porges Coloplast - 05708932705066

ImaJin™ Double loop ureteral stent silicone hydro-coated open/open CH FR 07 length 16 cm with steerable pusher
Coloplast A/S
BCHJ71
In Commercial Distribution

  • 05708932705073 ()
  • 05708932705066 ()

  • Catheter Gauge: 7 French
  • Length: 16 Centimeter
BCHJ71

  • Polymeric ureteral stent

Porges Coloplast - 05708932705035

ImaJin™ Double loop ureteral stent silicone hydro-coated open/open CH FR 06 length 30 cm with steerable pusher
Coloplast A/S
BCHJ66
In Commercial Distribution

  • 05708932705042 ()
  • 05708932705035 ()

  • Length: 30 Centimeter
  • Catheter Gauge: 6 French
BCHJ66

  • Polymeric ureteral stent

Porges Coloplast - 05708932704977

ImaJin™ Double loop ureteral stent silicone hydro-coated open/open CH FR 06 length 26 cm with steerable pusher
Coloplast A/S
BCHJ64
In Commercial Distribution

  • 05708932704984 ()
  • 05708932704977 ()

  • Catheter Gauge: 6 French
  • Length: 26 Centimeter
BCHJ64

  • Polymeric ureteral stent

Porges Coloplast - 05708932704915

ImaJin™ Double loop ureteral stent silicone hydro-coated open/open CH FR 06 length 22 cm with steerable pusher
Coloplast A/S
BCHJ67
In Commercial Distribution

  • 05708932704922 ()
  • 05708932704915 ()

  • Length: 22 Centimeter
  • Catheter Gauge: 6 French
BCHJ67

  • Polymeric ureteral stent

Porges Coloplast - 05708932704748

ImaJin™ Double loop ureteral stent silicone hydro-coated open/open CH FR 08 length 24 cm with steerable pusher
Coloplast A/S
BCHF83
In Commercial Distribution

  • 05708932704748 ()

  • Length: 24 Centimeter
  • Catheter Gauge: 8 French
BCHF83

  • Polymeric ureteral stent

Binder Lift - 00860012552184

Binder Transfer Ferno X1 & X2 Bundle (Sheet/Transfer-aid with set of 8 anchors)
We Stitch Stuff, LLC
BT-FBX5-BL
In Commercial Distribution

  • 00860012552184 ()
BT-FBX5-BL

  • Patient transfer/turning sheet, reusable

Porges Coloplast - 05708932704687

ImaJin™ Double loop ureteral stent silicone hydro-coated open/open CH FR 08 length 16 cm with steerable pusher
Coloplast A/S
BCHF81
In Commercial Distribution

  • 05708932704687 ()

  • Catheter Gauge: 8 French
  • Length: 16 Centimeter
BCHF81

  • Polymeric ureteral stent

Porges Coloplast - 05708932704625

ImaJin™ Double loop ureteral stent silicone hydro-coated open/open CH FR 07 length 28 cm with steerable pusher
Coloplast A/S
BCHF75
In Commercial Distribution

  • 05708932704625 ()

  • Catheter Gauge: 7 French
  • Length: 28 Centimeter
BCHF75

  • Polymeric ureteral stent

Porges Coloplast - 05708932704595

ImaJin™ Double loop ureteral stent silicone hydro-coated open/open CH FR 07 length 26 cm with steerable pusher
Coloplast A/S
BCHF74
In Commercial Distribution

  • 05708932704595 ()

  • Length: 26 Centimeter
  • Catheter Gauge: 7 French
BCHF74

  • Polymeric ureteral stent

Binder Lift - 00860012552115

Binder Transfer Anchors (set of 8) for Ferno iNX model
We Stitch Stuff, LLC
BT-FANX7-BL
In Commercial Distribution

  • 00860012552115 ()
BT-FANX7-BL

  • Patient transfer/turning sheet, reusable

Porges Coloplast - 05708932704533

ImaJin™ Double loop ureteral stent silicone hydro-coated open/open CH FR 07 length 22 cm with steerable pusher
Coloplast A/S
BCHF77
In Commercial Distribution

  • 05708932704533 ()

  • Length: 22 Centimeter
  • Catheter Gauge: 7 French
BCHF77

  • Polymeric ureteral stent

Porges Coloplast - 05708932704472

ImaJin™ Double loop ureteral stent silicone hydro-coated open/open CH FR 07 length 16 cm with steerable pusher
Coloplast A/S
BCHF71
In Commercial Distribution

  • 05708932704472 ()

  • Catheter Gauge: 7 French
  • Length: 16 Centimeter
BCHF71

  • Polymeric ureteral stent

Porges Coloplast - 05708932704380

ImaJin™ Double loop ureteral stent silicone hydro-coated open/open CH FR 06 length 26 cm with steerable pusher
Coloplast A/S
BCHF64
In Commercial Distribution

  • 05708932704380 ()

  • Length: 26 Centimeter
  • Catheter Gauge: 6 French
BCHF64

  • Polymeric ureteral stent

See Factor CT3 - 00860012510900

Mobile multimodality cone beam computed tomography scanner.
EPICA HUMAN HEALTH LLC
9801101000
In Commercial Distribution

  • 00860012510900 ()


  • Cone beam computed tomography system, head/neck

Porges Coloplast - 05708932704328

ImaJin™ Double loop ureteral stent silicone hydro-coated open/open CH FR 06 length 22 cm with steerable pusher
Coloplast A/S
BCHF67
In Commercial Distribution

  • 05708932704328 ()

  • Catheter Gauge: 6 French
  • Length: 22 Centimeter
BCHF67

  • Polymeric ureteral stent

Porges Coloplast - 05708932704267

ImaJin™ Double loop ureteral stent silicone hydro-coated open/open CH FR 06 length 16 cm with steerable pusher
Coloplast A/S
BCHF61
In Commercial Distribution

  • 05708932704267 ()

  • Length: 16 Centimeter
  • Catheter Gauge: 6 French
BCHF61

  • Polymeric ureteral stent

Porges Coloplast - 05708932704205

ImaJin™ Silicone hydro-coated Double loop ureteral stent open/open CH FR 08 length 28 cm with steerable pusher CH FR 08 and Orchestra™ guidewire and Flush ureteric catheter CH FR 06
Coloplast A/S
BCHT85
In Commercial Distribution

  • 05708932704205 ()

  • Length: 28 Centimeter
  • Catheter Gauge: 8 French
BCHT85

  • Polymeric ureteral stent

Porges Coloplast - 05708932704144

ImaJin™ Silicone hydro-coated Double loop ureteral stent open/open CH FR 08 length 24 cm with steerable pusher CH FR 08 and Orchestra™ guidewire and Flush ureteric catheter CH FR 06
Coloplast A/S
BCHT83
In Commercial Distribution

  • 05708932704144 ()

  • Length: 24 Centimeter
  • Catheter Gauge: 8 French
BCHT83

  • Polymeric ureteral stent

Porges Coloplast - 05708932704113

ImaJin™ Silicone hydro-coated Double loop ureteral stent open/open CH FR 08 length 20 cm with steerable pusher CH FR 08 and Orchestra™ guidewire and Flush ureteric catheter CH FR 06
Coloplast A/S
BCHT82
In Commercial Distribution

  • 05708932704113 ()

  • Catheter Gauge: 8 French
  • Length: 20 Centimeter
BCHT82

  • Polymeric ureteral stent

Porges Coloplast - 05708932704083

ImaJin™ Silicone hydro-coated Double loop ureteral stent open/open CH FR 08 length 16 cm with steerable pusher CH FR 08 and Orchestra™ guidewire and Flush ureteric catheter CH FR 06
Coloplast A/S
BCHT81
In Commercial Distribution

  • 05708932704083 ()

  • Catheter Gauge: 8 French
  • Length: 16 Centimeter
BCHT81

  • Polymeric ureteral stent

Porges Coloplast - 05708932704021

ImaJin™ Silicone hydro-coated Double loop ureteral stent open/open CH FR 07 length 28 cm with steerable pusher CH FR 06 and Orchestra™ guidewire and Flush ureteric catheter CH FR 06
Coloplast A/S
BCHT75
In Commercial Distribution

  • 05708932704021 ()

  • Catheter Gauge: 7 French
  • Length: 28 Centimeter
BCHT75

  • Polymeric ureteral stent

Porges Coloplast - 05708932703963

ImaJin™ Silicone hydro-coated Double loop ureteral stent open/open CH FR 07 length 24 cm with steerable pusher CH FR 06 and Orchestra™ guidewire and Flush ureteric catheter CH FR 06
Coloplast A/S
BCHT73
In Commercial Distribution

  • 05708932703963 ()

  • Catheter Gauge: 7 French
  • Length: 24 Centimeter
BCHT73

  • Polymeric ureteral stent

Xpeedy - 00860012318230

The Xpeedy DOA20 Automated Sample Preparation for Triple Quadrupole LC/MS/MS Analysis is used for fluid pre-treatment and processing of samples in a toxicology lab setting, serving the purpose of sample dilution, subpackaging, incubation and sample transferring.
Cura Diagnostics Inc.
DOA20
In Commercial Distribution

  • 00860012318230 ()


  • Pipetting system IVD

Porges Coloplast - 05708932703703

ImaJin™ Silicone hydro-coated Double loop ureteral stent open/open CH FR 06 length 22 cm with steerable pusher CH FR 06 and Orchestra™ guidewire and Flush ureteric catheter CH FR 06
Coloplast A/S
BCHT67
In Commercial Distribution

  • 05708932703703 ()

  • Catheter Gauge: 6 French
  • Length: 22 Centimeter
BCHT67

  • Polymeric ureteral stent

Titanium Grasper - 00860012315505

The GI Windows Titanium Grasper is a surgical laparoscopic grasper with a non-ferrous distal actuator that is intended to be used with GIW’s Self-Forming Magnet (SFM) technology. The grasper’s form factor, handle, length, and actuation will be nearly identical to commercially available laparoscopic graspers that we used every day in the operating room. The primary differentiator of this product will be the titanium distal actuator, which due to its non-ferrous make up, will not create (or minimally create) a magnetic attraction force to the SFM implants while in use in surgery.
G.I. Windows, Inc.
200123
In Commercial Distribution

  • 00860012315505 ()


  • Surgical soft-tissue manipulation forceps, scissors-like, reusable

Porges Coloplast - 05708932703468

ImaJin™ Silicone hydro-coated Double loop ureteral stent open/open CH FR 08 length 16 cm with steerable pusher CH FR 08 and Orchestra™ guidewire
Coloplast A/S
BCHS81
In Commercial Distribution

  • 05708932703468 ()

  • Length: 16 Centimeter
  • Catheter Gauge: 8 French
BCHS81

  • Polymeric ureteral stent
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