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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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Introducer set with hemostatic valve, 6F
Oscor Inc.
DYNJINTROL6
Not in Commercial Distribution

  • 40888277000026 ()
  • 00888277000028 ()

  • Needle 18 G
  • Sheath Length 23 cm
  • Syringe 10 cc
  • Guidewire Length: 50 cm, OD: 0.038 in
  • Dilator Length 28 cm
  • Lumen/Inner Diameter: 2.2 Millimeter
DYNJINTROL6

  • Vascular catheter introduction set, nonimplantable
Introducer set with hemostatic valve, 5F
Oscor Inc.
DYNJINTROL5
Not in Commercial Distribution

  • 40888277000019 ()
  • 00888277000011 ()

  • Sheath Length 23 cm
  • Syringe 10 cc
  • Dilator Length 28 cm
  • Guidewire Length: 50 cm, OD: 0.038 in
  • Needle 18 G
  • Lumen/Inner Diameter: 1.9 Millimeter
DYNJINTROL5

  • Vascular catheter introduction set, nonimplantable
Introducer set with hemostatic valve, 4F
Oscor Inc.
DYNJINTROL4
Not in Commercial Distribution

  • 40888277000002 ()
  • 00888277000004 ()

  • Needle 18 G
  • Guidewire Length: 50 cm, OD: 0.038 in
  • Sheath Length 23 cm
  • Dilator Length 28 cm
  • Lumen/Inner Diameter: 1.4 Millimeter
  • Syringe 10 cc
DYNJINTROL4

  • Vascular catheter introduction set, nonimplantable
PEDICLE AWL, STRAIGHT WITH TROCAR
Si-Bone Inc.
502206
In Commercial Distribution

  • 00810055524747 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
No Description
BIO CONCEPT Co., Ltd.
152020
In Commercial Distribution

  • 06947600304197 ()


  • Dental implant system
No Description
BIO CONCEPT Co., Ltd.
056070
In Commercial Distribution

  • 06947600302070 ()


  • Dental implant system
SPK10831 Jackson Kit with ProneSafe
XODUS MEDICAL, INC.
SPK10831
In Commercial Distribution

  • 20787551004933 ()
  • 00787551004939 ()
SPK10831

  • Operating table patient positioning set, single-use
SPK10740 ProAxis Jackson with ProneSafe
XODUS MEDICAL, INC.
SPK10740
In Commercial Distribution

  • 20787551003646 ()
  • 00787551003642 ()
SPK10740

  • Operating table patient positioning set, single-use
This product is used to treat the hemorrhoids in assistance of anoscope for adults only.
Changzhou Health Microport Medical Device Co., Ltd
HM/601-5-B
In Commercial Distribution

  • 06951862291560 ()


  • Haemorrhoid ligation set
This product is used to treat the hemorrhoids in assistance of anoscope for adults only.
Changzhou Health Microport Medical Device Co., Ltd
HM/601-3-A
In Commercial Distribution

  • 06951862291539 ()


  • Haemorrhoid ligation set
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