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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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No Description
DERMARITE INDUSTRIES LLC
00229E
In Commercial Distribution

  • 00714196229229 ()
  • 01714196229228 ()


  • Exudate-absorbent dressing, non-gel, non-antimicrobial
Laparoscopic Trocar Sleeve
APPLIED MEDICAL RESOURCES CORPORATION
C0652
Not in Commercial Distribution

  • 10607915114951 ()
  • 00607915114954 ()

  • Length: 100 Millimeter
  • Lumen/Inner Diameter: 12 Millimeter


  • Laparoscopic access cannula, single-use
Laparoscopic Trocar Sleeve
APPLIED MEDICAL RESOURCES CORPORATION
C0651
Not in Commercial Distribution

  • 10607915114944 ()
  • 00607915114947 ()

  • Length: 100 Millimeter
  • Lumen/Inner Diameter: 11 Millimeter


  • Laparoscopic access cannula, single-use
BEQ-HMOD 70000-USA Adult Quadrox iD, BEQ-RF32 RotaFlow, Gas Filter
DATASCOPE CORP.
BEQ-TOP 53600
In Commercial Distribution

  • 00607567209978 ()
709000218

  • Cardiopulmonary bypass system blood tubing set
No Description
DATASCOPE CORP.
BEQ-T 8068
In Commercial Distribution

  • 00607567206113 ()
701066883

  • Cardiopulmonary bypass system blood tubing set
BEQ HMOD 30000 Blood Transfer Bag Better Bladder Blood Microfilter System Cardiopegia Filter Gas Filter Pediatric Temp Probe
DATASCOPE CORP.
BEQ-TOP 24105
Not in Commercial Distribution

  • 00607567205574 ()
701064757

  • Cardiopulmonary bypass system blood tubing set
BEQ-HMOD 30000 Soft Shell Venous Reser 800 ml Better Bladder 1/4 CDI Set Cell 1/4 system 100 Blood Microfilter system Prebypass filter Gas Filter Temperature Proble
DATASCOPE CORP.
BEQ-TOP 22702
Not in Commercial Distribution

  • 00607567202573 ()
701051179

  • Cardiopulmonary bypass system blood tubing set
Softshell venous reservoir 1900 BEQ-RF32 RotaFlow
DATASCOPE CORP.
BEQ-T 21308
Not in Commercial Distribution

  • 00607567207141 ()
701068376

  • Cardiopulmonary bypass system blood tubing set
Syvek Brace with Straps
Marine Polymer Technologies, Inc.
420-05
In Commercial Distribution

  • 10389142000039 ()
  • 00389142000032 ()


  • Wrist immobilizer, single-use
Reusable Probes with holes.
APPLIED MEDICAL RESOURCES CORPORATION
C6204
Not in Commercial Distribution

  • 00607915117078 ()

  • Length: 33 Centimeter
  • Outer Diameter: 10 Millimeter


  • Surgical irrigation/aspiration handpiece, reusable
AuDX branded Sentiero
PATH medical GmbH
100098-AU
In Commercial Distribution

  • 04260223143281 ()


  • Evoked-potential audiometer
No Description
Dynarex Corporation
4698
In Commercial Distribution

  • 00616784469836 ()
  • 00616784469812 ()


  • Surgical/emergency suction cannula, non-illuminating, single-use
Elastic Bandage with Self-Closure, 6"x5yds
Dynarex Corporation
3661
In Commercial Distribution

  • 00616784366135 ()
  • 00616784366128 ()
  • 00616784366111 ()


  • Skin treatment/dressing-supportive limb/finger bandage, single-use
Elastic Bandage with Self-Closure, 4"x5yds
Dynarex Corporation
3660
In Commercial Distribution

  • 00616784366036 ()
  • 00616784366029 ()
  • 00616784366012 ()


  • Skin treatment/dressing-supportive limb/finger bandage, single-use
Elastic Bandage with Self-Closure 3"x5yds
Dynarex Corporation
3659
In Commercial Distribution

  • 00616784365930 ()
  • 00616784365923 ()
  • 00616784365916 ()


  • Skin treatment/dressing-supportive limb/finger bandage, single-use
Elastic Bandage with Self-Closure, 2"x5yds
Dynarex Corporation
3658
In Commercial Distribution

  • 00616784365831 ()
  • 00616784365824 ()
  • 00616784365817 ()


  • Skin treatment/dressing-supportive limb/finger bandage, single-use
No Description
Dynarex Corporation
10710
In Commercial Distribution

  • 00616784071015 ()


  • Parallel bar exerciser, non-powered
Foot Stool with Handle, Weight Capacity 300 lbs.
Dynarex Corporation
10552
In Commercial Distribution

  • 00616784055213 ()


  • Footstool
Overbed Table with U-Base, Light Oak and White, 32"x16" Adjustable Height 28" to 43"
Dynarex Corporation
10455
In Commercial Distribution

  • 00616784045511 ()


  • Overbed table
Overbed Table with U-Base, Mahogany and White, 32"x16", Adjustable Height 28" to 43"
Dynarex Corporation
10454
In Commercial Distribution

  • 00616784045412 ()


  • Overbed table
Overbed Table with U-Base, Amber Cherry and White, 32"x16", Adjustable Height 28" to 43"
Dynarex Corporation
10453
In Commercial Distribution

  • 00616784045313 ()


  • Overbed table
No Description
Dynarex Corporation
10821
In Commercial Distribution

  • 00616784082110 ()


  • Surgical suction system collection container, single-use
angled, distal opening on top 2.5 mm, 25 cm
Spiggle & Theis Medizintechnik GmbH
50-347-25-L
In Commercial Distribution

  • 04250676742636 ()
50-347-25-L

  • Surgical irrigation/aspiration cannula, non-illuminating, reusable
No Description
Paradigm Spine GmbH
RAT20500
In Commercial Distribution

  • 04260148897689 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Paradigm Spine GmbH
HAT50005
In Commercial Distribution

  • 04260148896613 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Paradigm Spine GmbH
DAT50005
In Commercial Distribution

  • 04260148893322 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Simplex® HV with Gentamicin is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. Simplex® HV with Gentamicinn cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. Simplex® HV with Gentamicin does not emit a signal and does not pose a safety risk in a magnetic resonance environment.
OSARTIS GmbH
6195-1-001
In Commercial Distribution

  • 24260056885765 ()
  • 14260056885768 ()
  • 04260056885761 ()

  • Total Volume: 20 Milliliter
  • Weight: 40.8 Gram
6195-1-010

  • Orthopaedic cement, antimicrobial
The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display.
AIR TECHNIQUES, INC.
D5000QB
In Commercial Distribution

  • D678D5000QB0 ()
  • D678D5000QB1 ()

  • Weight: 43 Pound
  • Height: 14 Inch
  • Length: 18 Inch
  • Width: 15.5 Inch


  • Radiography digital imaging scanner
The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display.
AIR TECHNIQUES, INC.
D5000FB
In Commercial Distribution

  • D678D5000FB0 ()
  • D678D5000FB1 ()

  • Weight: 43 Pound
  • Height: 14 Inch
  • Length: 18 Inch
  • Width: 15.5 Inch


  • Radiography digital imaging scanner
central channel, outlet left side size 4, 42x98 mm
Spiggle & Theis Medizintechnik GmbH
40-318-04
In Commercial Distribution

  • 04250381885680 ()
40-318-04

  • Tongue depressor, surgical
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