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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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SPK10740 ProAxis Jackson with ProneSafe
XODUS MEDICAL, INC.
SPK10740
In Commercial Distribution

  • 20787551003646 ()
  • 00787551003642 ()
SPK10740

  • Operating table patient positioning set, single-use
Plastic Cylinder with Hex Ti
NOGA MEDICAL PRODUCTS LTD
B
In Commercial Distribution

  • 07290118141693 ()
PF1-0058

  • Dental implant system
Plastic Cylinder with Round Ti
NOGA MEDICAL PRODUCTS LTD
B
In Commercial Distribution

  • 07290118141686 ()
PF1-0057

  • Dental implant system
Direct Plastic Cylinder With Hex.
NOGA MEDICAL PRODUCTS LTD
B
In Commercial Distribution

  • 07290118141570 ()
PF1-0035

  • Dental implant system
No Description
PREMIA SPINE LTD
88048
In Commercial Distribution

  • 07290115935141 ()


  • Orthopaedic counter-torque/rod-pushing instrument
No Description
PREMIA SPINE LTD
88036
In Commercial Distribution

  • 07290115935127 ()


  • Orthopaedic instrument extractor
No Description
PREMIA SPINE LTD
86641
In Commercial Distribution

  • 07290115934489 ()


  • Surgical instrument handle, non-torque-limiting
No Description
PREMIA SPINE LTD
86567
In Commercial Distribution

  • 07290115934465 ()


  • Surgical instrument torque limiter
No Description
PREMIA SPINE LTD
86273
In Commercial Distribution

  • 07290115934328 ()


  • Surgical instrument handle, non-torque-limiting
No Description
MAZOR ROBOTICS LTD
TOL0078-01
In Commercial Distribution

  • 07290109183770 ()


  • Stereotactic surgery system probe, reusable
LATITUDE ® Communicator with Wand
BOSTON SCIENTIFIC CORPORATION
6481
In Commercial Distribution

  • 00802526580727 ()


  • Patient monitoring modem
LATITUDE ® Communicator with Wand
BOSTON SCIENTIFIC CORPORATION
6481
In Commercial Distribution

  • 00802526480485 ()


  • Multi-hole nuclear medicine system collimator, high-energy
BGEcare Elastic Bandage with Self-closure, 4in X 5 yards, Latex Free,12 rolls/box, 6 boxes/carton box
Henan Zhende Medical Products Co., Ltd.
EB070405011206NS
In Commercial Distribution

  • 06972403420034 ()
  • 06972403420027 ()


  • Skin treatment/dressing-supportive limb/finger bandage, single-use
BGEcare Elastic Bandage with Self-closure, 2in X 5 yards, 12 rolls/box, 6 boxes/carton box
Henan Zhende Medical Products Co., Ltd.
EB070205011206NS
In Commercial Distribution

  • 06972403420010 ()
  • 06972403420003 ()


  • Skin treatment/dressing-supportive limb/finger bandage, single-use
Introducer set with hemostatic valve, 9F
Oscor Inc.
DYNJINTROL9
Not in Commercial Distribution

  • 20889942000361 ()
  • 10889942000364 ()

  • Sheath Length 23 cm
  • Needle 18 G
  • Dilator Length 28 cm
  • Guidewire Length: 50 cm, OD: 0.038 in
  • Syringe 10 cc
  • Lumen/Inner Diameter: 3 Millimeter
DYNJINTROL9

  • Vascular catheter introduction set, nonimplantable
Introducer set with hemostatic valve, 12F
Oscor Inc.
DYNJINTROL12
Not in Commercial Distribution

  • 20889942000286 ()
  • 10889942000289 ()

  • Guidewire Length: 50 cm, OD: 0.038 in
  • Lumen/Inner Diameter: 4 Millimeter
  • Needle 18 G
  • Dilator Length 28 cm
  • Sheath Length 23 cm
  • Syringe 10 cc
DYNJINTROL12

  • Vascular catheter introduction set, nonimplantable
Introducer set with hemostatic valve, 10F
Oscor Inc.
DYNJINTROL10
Not in Commercial Distribution

  • 20889942000217 ()
  • 10889942000210 ()

  • Sheath Length 23 cm
  • Syringe 10 cc
  • Dilator Length 28 cm
  • Guidewire Length: 50 cm, OD: 0.038 in
  • Lumen/Inner Diameter: 3.4 Millimeter
  • Needle 18 G
DYNJINTROL10

  • Vascular catheter introduction set, nonimplantable
Introducer set with hemostatic valve, 8F
Oscor Inc.
DYNJINTROL8
Not in Commercial Distribution

  • 20889942000354 ()
  • 10889942000357 ()

  • Syringe 10 cc
  • Guidewire Length: 50 cm, OD: 0.038 in
  • Dilator Length 28 cm
  • Lumen/Inner Diameter: 2.7 Millimeter
  • Sheath Length 23 cm
  • Needle 18 G
DYNJINTROL8

  • Vascular catheter introduction set, nonimplantable
Introducer set with hemostatic valve, 7F
Oscor Inc.
DYNJINTROL7
Not in Commercial Distribution

  • 20889942000347 ()
  • 10889942000340 ()

  • Lumen/Inner Diameter: 2.4 Millimeter
  • Needle 18 G
  • Sheath Length 23 cm
  • Guidewire Length: 50 cm, OD: 0.038 in
  • Syringe 10 cc
  • Dilator Length 28 cm
DYNJINTROL7

  • Vascular catheter introduction set, nonimplantable
Introducer set with hemostatic valve, 11F
Oscor Inc.
DYNJINTROL11
Not in Commercial Distribution

  • 20889942000279 ()
  • 10889942000272 ()

  • Syringe 10 cc
  • Lumen/Inner Diameter: 3.7 Millimeter
  • Needle 18 G
  • Guidewire Length: 50 cm, OD: 0.038 in
  • Sheath Length 23 cm
  • Dilator Length 28 cm
DYNJINTROL11

  • Vascular catheter introduction set, nonimplantable
No Description
BIOPRO, INC.
22293
In Commercial Distribution

  • 00810012485760 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
4mm
In Commercial Distribution

  • 07290018434604 ()
SAW4

  • Dental implant system
No Description
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
3mm
In Commercial Distribution

  • 07290018434598 ()
SAW3

  • Dental implant system
No Description
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
2mm
In Commercial Distribution

  • 07290018434581 ()
SAW2

  • Dental implant system
No Description
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
1mm
In Commercial Distribution

  • 07290018434574 ()
SAW1

  • Dental implant system
Buck's Traction with Heel Hole
PRIMO INC
BT02-12
In Commercial Distribution

  • 00810006682991 ()
  • 00810006681581 ()
BT02-12

  • Freestanding patient positioner, single-use
Support sleeve with distal protector for working channel 4.1 mm
Nouvag AG
1915NOU
In Commercial Distribution

  • ENOU1915NOU0 ()


  • Orthopaedic bur, reusable
Support sleeve with distal protector for working channel 4.1 mm
Nouvag AG
1749NOU
In Commercial Distribution

  • ENOU1749NOU9 ()


  • Orthopaedic bur, reusable
Support sleeve with distal protector for working channel 4.1 mm
Nouvag AG
1737NOU
In Commercial Distribution

  • ENOU1737NOU9 ()


  • Orthopaedic bur, reusable
No Description
CAPTIVA SPINE, INC.
PI-0705
In Commercial Distribution

  • M739PI0705 ()


  • Bone curette, reusable
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