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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PLATE, MICRO, Y SHP, 1.5 MM SCREW, CP TITANIUM
KLS-Martin L.P.
25-329-05-09
In Commercial Distribution

  • 00888118039002 ()

  • 5 HOLE, T=0.6 MM


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE, MICRO, H SHP, 140*, 1.5 MM SCREW, CP TITANIUM
KLS-Martin L.P.
25-329-02-09
In Commercial Distribution

  • 00888118038999 ()

  • 12 HOLE, T=0.6 MM


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE, MICRO, H SHP, 140*, 1.5 MM SCREW, CP TITANIUM
KLS-Martin L.P.
25-329-01-09
In Commercial Distribution

  • 00888118038982 ()

  • 11 HOLE, T=0.6 MM


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE, MICRO, H SHP, 1.5 MM SCREW, CP TITANIUM
KLS-Martin L.P.
25-328-12-91
In Commercial Distribution

  • 00888118038975 ()

  • 12 HOLE, T=0.6 MM


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE, MICRO, X SHP, 1.5 MM SCREW, CP TITANIUM
KLS-Martin L.P.
25-326-55-91
In Commercial Distribution

  • 00888118038968 ()

  • 4 HOLE, T=0.6 MM


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE, MICRO, CVD, 1.5 MM SCREW, CP TITANIUM
KLS-Martin L.P.
25-325-16-09
Not in Commercial Distribution

  • 00888118038951 ()

  • 16 HOLE, 57 MM, T=0.6 MM


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE, MICRO, CVD, 1.5 MM SCREW, CP TITANIUM
KLS-Martin L.P.
25-325-10-91
In Commercial Distribution

  • 00888118038944 ()

  • 10 HOLE, 38 MM, T=0.6 MM


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE, MICRO, CVD, 1.5 MM SCREW, CP TITANIUM
KLS-Martin L.P.
25-325-08-91
In Commercial Distribution

  • 00888118038937 ()

  • 8 HOLE, 31 MM, T=0.6 MM


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE, MICRO, CVD, 1.5 MM SCREW, CP TITANIUM
KLS-Martin L.P.
25-325-06-91
In Commercial Distribution

  • 00888118038920 ()

  • 6 HOLE, 23 MM, T=0.6 MM


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
One Touch SureSoft Single Use Disposable Lancing Device
LifeScan Europe GmbH
021-140
In Commercial Distribution

  • 20353885006839 ()
  • 00353885006835 ()
  • 53885-140-20 ()
  • 80353885006831 ()

  • Needle Gauge: 28 Gauge


  • Manual blood lancing device, single-use
One Touch SureSoft Single Use Disposable Lancing Device
LifeScan Europe GmbH
021-139
In Commercial Distribution

  • 53885-139-20 ()
  • 00353885006828 ()
  • 80353885006824 ()
  • 20353885006822 ()

  • Needle Gauge: 21 Gauge


  • Manual blood lancing device, single-use
No Description
Happersberger Otopront GmbH
SIT MAX one
In Commercial Distribution

  • 04260154540258 ()


  • ENT chair, electric
First Check Home Drug Test One Drug Marijuana
FIRST CHECK DIAGNOSTIC CORP.
One Drug Marijuana
Not in Commercial Distribution

  • 00643281061553 ()
THC

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
No Description
VAREX IMAGING CORPORATION
Platinum One DSA
In Commercial Distribution

  • 00854344007122 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Platinum One RF
In Commercial Distribution

  • 00854344007085 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
Philips North America LLC
Bernoulli One Software
In Commercial Distribution

  • 00854709006029 ()


  • Centralized patient monitor
No Description
R82 A/S
Orca ONE SIZE
In Commercial Distribution

  • 05707292578099 ()
87550

  • Portable reclining bathtub
No Description
NEW INTERNATIONAL VISION
ONE LOVE Ecaille
In Commercial Distribution

  • 03701629010780 ()


  • Prescription spectacles
No Description
NEW INTERNATIONAL VISION
ONE LOVE Orange
In Commercial Distribution

  • 03701629010766 ()


  • Prescription spectacles
No Description
NEW INTERNATIONAL VISION
ONE LOVE Purple
In Commercial Distribution

  • 03701629010759 ()


  • Prescription spectacles
No Description
NEW INTERNATIONAL VISION
ONE LOVE Red
In Commercial Distribution

  • 03701629010742 ()


  • Prescription spectacles
One Piece Dental Implant 8.0mm diameter and 17mm in length crown and bridge head
Suncoast Dental, Inc
One Piece/8.0x17CB
Not in Commercial Distribution

  • 00083208180170 ()

  • One Piece Dental Implant 8.0mm diameter and 17mm in length crown and bridge head
  • Outer Diameter: 8 Millimeter
  • Length: 17 Millimeter
ITO8.0x17CB

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 8.0mm diameter and 14mm in length crown and bridge head
Suncoast Dental, Inc
One Piece/8.0x14CB
In Commercial Distribution

  • 00083208180149 ()

  • One Piece Dental Implant 8.0mm diameter and 14mm in length crown and bridge head
  • Outer Diameter: 8 Millimeter
  • Length: 14 Millimeter
ITO 8.0 x 14mm (CB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 8.0mm diameter and 11mm in length crown and bridge head
Suncoast Dental, Inc
One Piece/8.0x11CB
In Commercial Distribution

  • 00083208180118 ()

  • One Piece Dental Implant 8.0mm diameter and 11mm in length crown and bridge head
  • Length: 11 Millimeter
  • Outer Diameter: 8 Millimeter
ITO 8.0 x 11mm (CB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 7.0mm diameter and 17mm in length crown and bridge head
Suncoast Dental, Inc
One Piece/7.0x17CB
Not in Commercial Distribution

  • 00083208170171 ()

  • One Piece Dental Implant 7.0mm diameter and 17mm in length crown and bridge head
  • Outer Diameter: 7 Millimeter
  • Length: 17 Millimeter
ITO7.0x17CB

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 7.0mm diameter and 14mm in length crown and bridge head
Suncoast Dental, Inc
One Piece/7.0x14CB
In Commercial Distribution

  • 00083208170140 ()

  • Outer Diameter: 7 Millimeter
  • One Piece Dental Implant 7.0mm diameter and 14mm in length crown and bridge head
  • Length: 14 Millimeter
ITO 7.0 x 14mm (CB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 7.0mm diameter and 11mm in length crown and bridge head
Suncoast Dental, Inc
One Piece/7.0x11CB
In Commercial Distribution

  • 00083208170119 ()

  • One Piece Dental Implant 7.0mm diameter and 11mm in length crown and bridge head
  • Length: 11 Millimeter
  • Outer Diameter: 7 Millimeter
ITO 7.0 x 11mm (CB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 5.0mm diameter and 23mm in length crown and bridge head
Suncoast Dental, Inc
One Piece/5.0x23CB
Not in Commercial Distribution

  • 00083208150234 ()

  • One Piece Dental Implant 5.0mm diameter and 23mm in length crown and bridge head
  • Outer Diameter: 5 Millimeter
  • Length: 23 Millimeter
ITO5.0x23CB

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 5.0mm diameter and 20mm in length crown and bridge head
Suncoast Dental, Inc
One Piece/5.0x20CB
Not in Commercial Distribution

  • 00083208150203 ()

  • One Piece Dental Implant 5.0mm diameter and 20mm in length crown and bridge head
  • Outer Diameter: 5 Millimeter
  • Length: 20 Millimeter
ITO5.0x20CB

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 4.5mm diameter and 23mm in length crown and bridge head
Suncoast Dental, Inc
One Piece/4.5x23CB
Not in Commercial Distribution

  • 00083208145230 ()

  • One Piece Dental Implant 4.5mm diameter and 23mm in length crown and bridge head
  • Length: 23 Millimeter
  • Outer Diameter: 4.5 Millimeter
ITO 4.5 x 23mm (CB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 4.5mm diameter and 20mm in length crown and bridge head
Suncoast Dental, Inc
One Piece/4.5x20CB
Not in Commercial Distribution

  • 00083208145209 ()

  • Outer Diameter: 4.5 Millimeter
  • One Piece Dental Implant 4.5mm diameter and 20mm in length crown and bridge head
  • Length: 20 Millimeter
ITO 4.5 x 20mm (CB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 4.5mm diameter and 17mm in length crown and bridge head
Suncoast Dental, Inc
One Piece/4.5x17CB
In Commercial Distribution

  • 00083208145179 ()

  • Outer Diameter: 4.5 Millimeter
  • One Piece Dental Implant 4.5mm diameter and 17mm in length crown and bridge head
  • Length: 17 Millimeter
ITO 4.5 x 17mm (CB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 4.5mm diameter and 14mm in length crown and bridge head
Suncoast Dental, Inc
One Piece/4.5x14CB
In Commercial Distribution

  • 00083208145148 ()

  • One Piece Dental Implant 4.5mm diameter and 14mm in length crown and bridge head
  • Length: 14 Millimeter
  • Outer Diameter: 4.5 Millimeter
ITO 4.5 x 14mm (CB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 4.5mm diameter and 11mm in length crown and bridge head
Suncoast Dental, Inc
One Piece/4.5x11CB
In Commercial Distribution

  • 00083208145117 ()

  • One Piece Dental Implant 4.5mm diameter and 11mm in length crown and bridge head
  • Outer Diameter: 4.5 Millimeter
  • Length: 11 Millimeter
ITO 4.5 x 11mm (CB)

  • Screw endosteal dental implant, one-piece
Nu TempCement NE - One Syringe Kit
NU RADIANCE INC
One Syringe Kit
In Commercial Distribution

  • B77207780 ()
0778

  • Dental acrylic resin
AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY
BIOPSYBELL SRL
ESTER ONE SHOT
In Commercial Distribution

  • 08033860035150 ()

  • Length: 100 Millimeter
  • Needle Gauge: 20 Gauge
GUN2010EC-OS

  • End-cut biopsy gun handpiece/needle
AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY
BIOPSYBELL SRL
ESTER ONE SHOT
In Commercial Distribution

  • 08033860028459 ()

  • Length: 150 Millimeter
  • Needle Gauge: 20 Gauge
GUN2015EC-OS

  • End-cut biopsy gun handpiece/needle
AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY
BIOPSYBELL SRL
ESTER ONE SHOT
In Commercial Distribution

  • 08033860028442 ()

  • Length: 200 Millimeter
  • Needle Gauge: 20 Gauge
GUN2020EC-OS

  • End-cut biopsy gun handpiece/needle
AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY
BIOPSYBELL SRL
ESTER ONE SHOT
In Commercial Distribution

  • 08033860026431 ()

  • Length: 200 Millimeter
  • Needle Gauge: 16 Gauge
GUN1620EC-OS

  • End-cut biopsy gun handpiece/needle
Smart Spirometer and Oximeter connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Smart One Oxi
In Commercial Distribution

  • 08052990321704 ()


  • Expiratory peak flow meter, digital
  • Pulse oximeter
Peak low and FEV1 meter
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Smart One USA
In Commercial Distribution

  • 08052990321681 ()


  • Expiratory peak flow meter, digital
AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY
BIOPSYBELL SRL
ESTER ONE SHOT
In Commercial Distribution

  • 08033860026417 ()

  • Length: 100 Millimeter
  • Needle Gauge: 18 Gauge
GUN1810EC-OS

  • End-cut biopsy gun handpiece/needle
AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY
BIOPSYBELL SRL
ESTER ONE SHOT
In Commercial Distribution

  • 08033860024666 ()

  • Length: 250 Millimeter
  • Needle Gauge: 14 Gauge
GUN1425EC-OS

  • End-cut biopsy gun handpiece/needle
AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY
BIOPSYBELL SRL
ESTER ONE SHOT
In Commercial Distribution

  • 08033860024642 ()

  • Length: 200 Millimeter
  • Needle Gauge: 14 Gauge
GUN1420EC-OS

  • End-cut biopsy gun handpiece/needle
AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY
BIOPSYBELL SRL
ESTER ONE SHOT
In Commercial Distribution

  • 08033860023584 ()

  • Length: 100 Millimeter
  • Needle Gauge: 16 Gauge
GUN1610EC-OS

  • End-cut biopsy gun handpiece/needle
AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY
BIOPSYBELL SRL
ESTER ONE SHOT
In Commercial Distribution

  • 08033860017781 ()

  • Length: 250 Millimeter
  • Needle Gauge: 16 Gauge
GUN1625EC-OS

  • End-cut biopsy gun handpiece/needle
AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY
BIOPSYBELL SRL
ESTER ONE SHOT
In Commercial Distribution

  • 08033860017705 ()

  • Length: 100 Millimeter
  • Needle Gauge: 14 Gauge
GUN1410EC-OS

  • End-cut biopsy gun handpiece/needle
AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY
BIOPSYBELL SRL
ESTER ONE SHOT
In Commercial Distribution

  • 08033860016531 ()

  • Length: 250 Millimeter
  • Needle Gauge: 18 Gauge
GUN1825EC-OS

  • End-cut biopsy gun handpiece/needle
AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY
BIOPSYBELL SRL
ESTER ONE SHOT
In Commercial Distribution

  • 08033860016357 ()

  • Length: 150 Millimeter
  • Needle Gauge: 18 Gauge
GUN1815EC-OS

  • End-cut biopsy gun handpiece/needle
AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY
BIOPSYBELL SRL
ESTER ONE SHOT
In Commercial Distribution

  • 08033860016333 ()

  • Length: 200 Millimeter
  • Needle Gauge: 18 Gauge
GUN1820EC-OS

  • End-cut biopsy gun handpiece/needle
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