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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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
central channel, outlet left side size 3, 39x85 mm
Spiggle & Theis Medizintechnik GmbH
40-318-03
In Commercial Distribution

  • 04250381885673 ()
40-318-03

  • Tongue depressor, surgical
central channel, outlet left side size 2, 34x80 mm
Spiggle & Theis Medizintechnik GmbH
40-318-02
In Commercial Distribution

  • 04250381885666 ()
40-318-02

  • Tongue depressor, surgical
central channel, outlet left side size 1, 30x70 mm
Spiggle & Theis Medizintechnik GmbH
40-318-01
In Commercial Distribution

  • 04250381885659 ()
40-318-01

  • Tongue depressor, surgical
curved upwards, 90°, bayonet 1 mm, 27 cm
Spiggle & Theis Medizintechnik GmbH
90-210-02
In Commercial Distribution

  • 04250381870365 ()
90-210-02

  • Soft-tissue surgical hook, reusable
for 15 micro instruments 215x222x38 mm
Spiggle & Theis Medizintechnik GmbH
80-603-04
In Commercial Distribution

  • 04250381869154 ()
80-603-04

  • Device sterilization/disinfection container, reusable
for 10 hooks/knives 117.5x222x38 mm
Spiggle & Theis Medizintechnik GmbH
80-603-03
In Commercial Distribution

  • 04250381869017 ()
80-603-03

  • Device sterilization/disinfection container, reusable
angled, distal opening on top 3.0 mm, 25 cm
Spiggle & Theis Medizintechnik GmbH
50-347-30
In Commercial Distribution

  • 04250381858844 ()
50-347-30

  • Surgical irrigation/aspiration cannula, non-illuminating, reusable
angled, distal opening on top 2.5 mm, 25 cm
Spiggle & Theis Medizintechnik GmbH
50-347-25
In Commercial Distribution

  • 04250381858837 ()
50-347-25

  • Surgical irrigation/aspiration cannula, non-illuminating, reusable
angled, distal opening on top 2.0 mm, 25 cm
Spiggle & Theis Medizintechnik GmbH
50-347-20
In Commercial Distribution

  • 04250381858820 ()
50-347-20

  • Surgical irrigation/aspiration cannula, non-illuminating, reusable
for 30 "Hooks/Knives" 381x222x38 mm
Spiggle & Theis Medizintechnik GmbH
80-603-02
In Commercial Distribution

  • 04250381846018 ()
80-603-02

  • Device sterilization/disinfection container, reusable
for 20 "Hooks/Knives" 278x222x38mm
Spiggle & Theis Medizintechnik GmbH
80-603-01
In Commercial Distribution

  • 04250381826225 ()
80-603-01

  • Device sterilization/disinfection container, reusable
15 cm, 3 mm, incl. stylet
Spiggle & Theis Medizintechnik GmbH
30-450-30
In Commercial Distribution

  • 04250381813904 ()
30-450-30

  • Bone-coring punch, reusable
18 cm, 2 mm, incl. stylet
Spiggle & Theis Medizintechnik GmbH
30-450-20
In Commercial Distribution

  • 04250381813898 ()
30-450-20

  • Bone-coring punch, reusable
No Description
Noras MRI products GmbH
13
In Commercial Distribution

  • 04251269201516 ()
113120

  • MRI system coil, radio-frequency
No Description
PROTEK MEDICAL PRODUCTS, INC.
1217
In Commercial Distribution

  • 10841912100672 ()
  • 00841912100675 ()
1217

  • Medical equipment/instrument drape, single-use
Multifunctional Mirror with Suction
DiaDent Group International
Plastic adapter 16mm
In Commercial Distribution

  • 08806383524483 ()
901-403

  • Dental mirror, reusable
Multifunctional Mirror with Suction
DiaDent Group International
Plastic adapter 18mm
In Commercial Distribution

  • 08806383524476 ()
901-404

  • Dental mirror, reusable
Multifunctional Mirror with Suction
DiaDent Group International
Plastic adapter
In Commercial Distribution

  • 08806383524469 ()
901-401

  • Dental mirror, reusable
Multifunctional Mirror with Suction
DiaDent Group International
YELLOW
In Commercial Distribution

  • 08806383524377 ()
901-101

  • Dental mirror, reusable
AEROBIKA OPEP with Manometer (package of 10)
Trudell Medical International
110504
Not in Commercial Distribution

  • 62860110504023 ()
  • 62860110504016 ()
11050494010

  • Positive pressure airway secretion-clearing device
Spatula non-stick with cable
ORANGE SURGICAL INSTRUMENTS, LLC
OSSPAT445C
Not in Commercial Distribution

  • B354OSSPAT445C10 ()
  • B354OSSPAT445C0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
Reusable Handle with Ratchet
ORANGE SURGICAL INSTRUMENTS, LLC
OSRMHRB
In Commercial Distribution

  • B35400 ()
  • B354OSRMHRB9 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
Reusable Handle with Ratchet
ORANGE SURGICAL INSTRUMENTS, LLC
OSRMHRB
In Commercial Distribution

  • B35400 ()
  • B354OSRMHRB4 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
Reusable Handle with Ratchet
ORANGE SURGICAL INSTRUMENTS, LLC
OSRMHRB
In Commercial Distribution

  • B35400 ()
  • B354OSRMHRB2 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
Reusable Handle with Ratchet
ORANGE SURGICAL INSTRUMENTS, LLC
OSRMHRB
In Commercial Distribution

  • B354OSRMHRB10 ()
  • B354OSRMHRB0 ()


  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Spatula non-stick with cable
ORANGE SURGICAL INSTRUMENTS, LLC
OSSPAT335C
Not in Commercial Distribution

  • B354OSSPAT335C10 ()
  • B354OSSPAT335C0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
Reusable Handle with Ratchet
ORANGE SURGICAL INSTRUMENTS, LLC
OSRMHRB
In Commercial Distribution

  • B35400 ()
  • B354OSRMHRB5 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
Reusable Handle with Ratchet
ORANGE SURGICAL INSTRUMENTS, LLC
OSRMHRB
In Commercial Distribution

  • B35400 ()
  • B354OSRMHRB3 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
Reusable Handle with Ratchet
ORANGE SURGICAL INSTRUMENTS, LLC
OSRMHRB
In Commercial Distribution

  • B35400 ()
  • B354OSRMHRB1 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
No Description
Biomet Orthopedics, LLC
A11
In Commercial Distribution

  • 00887868070310 ()
A11

  • External orthopaedic fixation system, single-use
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