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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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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Coloplast A/S
BCHS75
In Commercial Distribution

  • 05708932703406 ()

  • Length: 28 Centimeter
  • Catheter Gauge: 7 French
BCHS75

  • Polymeric ureteral stent
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
Coloplast A/S
BCHS73
In Commercial Distribution

  • 05708932703345 ()

  • Length: 24 Centimeter
  • Catheter Gauge: 7 French
BCHS73

  • Polymeric ureteral stent
ImaJin™ Silicone hydro-coated Double loop ureteral stent open/open CH FR 07 length 20 cm with steerable pusher CH FR 06 and Orchestra™ guidewire
Coloplast A/S
BCHS72
In Commercial Distribution

  • 05708932703284 ()

  • Length: 20 Centimeter
  • Catheter Gauge: 7 French
BCHS72

  • Polymeric ureteral stent
ImaJin™ Silicone hydro-coated Double loop ureteral stent open/open CH FR 06 length 30 cm with steerable pusher CH FR 06 and Orchestra™ guidewire
Coloplast A/S
BCHS66
In Commercial Distribution

  • 05708932703222 ()

  • Catheter Gauge: 6 French
  • Length: 30 Centimeter
BCHS66

  • Polymeric ureteral stent
ImaJin™ Silicone hydro-coated Double loop ureteral stent open/open CH FR 06 length 24 cm with steerable pusher CH FR 06 and Orchestra™ guidewire
Coloplast A/S
BCHS63
In Commercial Distribution

  • 05708932703130 ()

  • Catheter Gauge: 6 French
  • Length: 24 Centimeter
BCHS63

  • Polymeric ureteral stent
ImaJin™ Silicone hydro-coated Double loop ureteral stent open/open CH FR 06 length 20 cm with steerable pusher CH FR 06 and Orchestra™ guidewire
Coloplast A/S
BCHS62
In Commercial Distribution

  • 05708932703079 ()

  • Length: 20 Centimeter
  • Catheter Gauge: 6 French
BCHS62

  • Polymeric ureteral stent
Size 3 Fitting Pessary
Reia, LLC
FP01-3
In Commercial Distribution

  • 00860012119356 ()


  • Pelvic-organ-supporting pessary
Size 1 Fitting Pessary
Reia, LLC
FP01-1
In Commercial Distribution

  • 00860012119332 ()


  • Pelvic-organ-supporting pessary
Size 1 Patient Pessary
Reia, LLC
PP01-1
In Commercial Distribution

  • 00860012119301 ()


  • Pelvic-organ-supporting pessary
SabreLine Reusable Laser Fiber 940um
Coloplast A/S
RUS940
In Commercial Distribution

  • 05708932688543 ()

  • Outer Diameter: 940 Micrometer
RUS940

  • Urogenital surgical laser system beam guide, reusable
SabreLine Reusable Laser Fiber 550um
Coloplast A/S
RUS550
In Commercial Distribution

  • 05708932688512 ()

  • Outer Diameter: 550 Micrometer
RUS550

  • Urogenital surgical laser system beam guide, reusable
SabreLine Single Use Laser Fiber 550um
Coloplast A/S
SUD550
In Commercial Distribution

  • 05708932688390 ()
  • 05708932688383 ()

  • Outer Diameter: 550 Micrometer
SUD550

  • Urogenital surgical laser system beam guide, single-use
SabreLine Single Use Laser Fiber 272um
Coloplast A/S
SUE272
In Commercial Distribution

  • 05708932688338 ()
  • 05708932688321 ()

  • Outer Diameter: 272 Micrometer
SUE272

  • Urogenital surgical laser system beam guide, single-use
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