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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Pre-Operative Skin Marker
DEROYAL INDUSTRIES, INC.
26-017NS
In Commercial Distribution

  • 30749756643208 ()
  • 00749756643207 ()
  • 50749756643202 ()
26-017NS

  • Skin marking pen, single-use
Pre-Operative Skin Marker
DEROYAL INDUSTRIES, INC.
26-018PRNS
In Commercial Distribution

  • 50749756873340 ()
  • 00749756873345 ()
26-018PRNS

  • Skin marking pen, single-use
SKIN PREP TRAY
Cardinal Health 200, LLC
39-4133A
In Commercial Distribution

  • 50195594742483 ()
  • 10195594742485 ()
39-4133A

  • General surgical procedure kit, medicated
Skin Temperature Sensor
DEROYAL INDUSTRIES, INC.
81-010700
In Commercial Distribution

  • 50749756046171 ()
  • 00749756046176 ()


  • General-purpose patient temperature probe, single-use
Skin Temperature Sensor
DEROYAL INDUSTRIES, INC.
81-010400
In Commercial Distribution

  • 50749756046164 ()
  • 00749756046169 ()


  • General-purpose patient temperature probe, single-use
SKIN PREP TRAY
Cardinal Health 200, LLC
39-7603A
In Commercial Distribution

  • 50197106203772 ()
  • 10197106203774 ()
39-7603A

  • General surgical procedure kit, non-medicated, single-use
SKIN PREP TRAY
Cardinal Health 200, LLC
39-5418C
In Commercial Distribution

  • 50197106202652 ()
  • 10197106202654 ()
39-5418C

  • General surgical procedure kit, medicated
SKIN PREP TRAY
Cardinal Health 200, LLC
39-0538B
In Commercial Distribution

  • 50197106499885 ()
  • 10197106499887 ()
39-0538B

  • Surgical patient preparation kit
SKIN PREP TRAY
Cardinal Health 200, LLC
39-6662B
In Commercial Distribution

  • 50197106110704 ()
  • 10197106110706 ()
39-6662B

  • General surgical procedure kit, non-medicated, single-use
SKIN PREP TRAY
Cardinal Health 200, LLC
39-6662A
In Commercial Distribution

  • 50197106043019 ()
  • 10197106043011 ()
39-6662A

  • General surgical procedure kit, non-medicated, single-use
SKIN TREATMENT TRAY
Cardinal Health 200, LLC
SBA55SKSC5
In Commercial Distribution

  • 50195594658036 ()
  • 10195594658038 ()
SBA55SKSC5

  • General surgical procedure kit, medicated
Topical Skin Adhesive
Covidien LP
SS6
In Commercial Distribution

  • 30884521196777 ()
  • 10884521196773 ()
  • 20884521196770 ()

  • Total Volume: 0.8 Milliliter


  • Skin-approximation adhesive
Skin Stapler Reload
Covidien LP
050284
In Commercial Distribution

  • 20884521080734 ()
  • 10884521080737 ()

  • Width,N/A,N/A;


  • Surgical staple loading unit, non-cutting
Skin Stapler Reload
Covidien LP
050258
Not in Commercial Distribution

  • 20884521080727 ()
  • 10884521080720 ()

  • Regular,N/A,N/A;


  • Surgical staple loading unit, non-cutting
iTero Lumina Pro US Scanning Unit, RMA
Align Technology, Inc.
222049
In Commercial Distribution

  • 00816063022664 ()


  • Intraoral optical scanning system
iTero Lumina Pro US Scanning Unit
Align Technology, Inc.
222047
In Commercial Distribution

  • 00816063022657 ()


  • Intraoral optical scanning system
iTero Lumina Pro US upgrade from Lumina
Align Technology, Inc.
221950
In Commercial Distribution

  • 00816063022466 ()


  • Intraoral optical scanning system
iTero Lumina Pro US Mobile Configuration
Align Technology, Inc.
221952
In Commercial Distribution

  • 00816063022237 ()


  • Intraoral optical scanning system
iTero Lumina Pro US Cart Configuration
Align Technology, Inc.
221951
In Commercial Distribution

  • 00816063022213 ()


  • Intraoral optical scanning system
The BreathID® Hp Lab System is intended for use to non-invasively measure changes in the 13CO2/ 12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Hp Lab System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp Lab System consists of the appropriate IDkit: Hp™ kit, and the BreathID® Hp device, Auto Sampler and Lab Application
MERIDIAN BIOSCIENCE ISRAEL LTD
VS02000W
In Commercial Distribution

  • 07290016923391 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram


  • Infrared spectrometry breath analyser IVD
The BreathID® Hp Lab System is intended for use to non-invasively measure changes in the 13CO2/ 12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Hp Lab System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp Lab System consists of the appropriate IDkit: Hp™ kit, and the BreathID® Hp device, Auto Sampler and Lab Application
MERIDIAN BIOSCIENCE ISRAEL LTD
VS02000
In Commercial Distribution

  • 07290016923384 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram


  • Infrared spectrometry breath analyser IVD
The BreathID® Smart System is intended for use to non-invasively measure changes in the 13CO2/12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Smart System is indicated for use as an aid in the initial diagnosis and post treatment monitoring H. pylori of infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Smart System consists of the appropriate IDkit: Hp™ kit and the BreathID® Smart device.
MERIDIAN BIOSCIENCE ISRAEL LTD
VS07000WR
Not in Commercial Distribution

  • 07290016923353 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram


  • Infrared spectrometry breath analyser IVD
The BreathID® Smart System is intended for use to non-invasively measure changes in the 13CO2/12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Smart System is indicated for use as an aid in the initial diagnosis and post treatment monitoring H. pylori of infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Smart System consists of the appropriate IDkit: Hp™ kit and the BreathID® Smart device.
MERIDIAN BIOSCIENCE ISRAEL LTD
VS07000W
In Commercial Distribution

  • 07290016923346 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram


  • Infrared spectrometry breath analyser IVD
The BreathID® Smart System is intended for use to non-invasively measure changes in the 13CO2/12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Smart System is indicated for use as an aid in the initial diagnosis and post treatment monitoring H. pylori of infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Smart System consists of the appropriate IDkit: Hp™ kit and the BreathID® Smart device.
MERIDIAN BIOSCIENCE ISRAEL LTD
VS07000R
Not in Commercial Distribution

  • 07290016923278 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram


  • Infrared spectrometry breath analyser IVD
The BreathID® Smart System is intended for use to non-invasively measure changes in the 13CO2/12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Smart System is indicated for use as an aid in the initial diagnosis and post treatment monitoring H. pylori of infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Smart System consists of the appropriate IDkit: Hp™ kit and the BreathID® Smart device.
MERIDIAN BIOSCIENCE ISRAEL LTD
VS07000
In Commercial Distribution

  • 07290016923223 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram


  • Infrared spectrometry breath analyser IVD
The BreathID® Hp Lab System is intended for use to non-invasively measure changes in the 13CO2/ 12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Hp Lab System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp Lab System consists of the appropriate IDkit: Hp™ kit, and the BreathID® Hp device, Auto Sampler and Lab Application
MERIDIAN BIOSCIENCE ISRAEL LTD
VS01082R
Not in Commercial Distribution

  • 07290016923162 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram
  • Height: 10 Inch
  • Width: 15.7 Inch
  • Depth: 18 Inch
  • Weight: 9 Kilogram


  • Infrared spectrometry breath analyser IVD
The BreathID® Hp System is intended for use to continually and non-invasively measure changes in the13CO2 /12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Hp System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp System consists of the appropriate IDkit:Hp™ kit and the BreathID® Hp test device.
MERIDIAN BIOSCIENCE ISRAEL LTD
VS01000R
Not in Commercial Distribution

  • 07290016923148 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram
VS01000R

  • Infrared spectrometry breath analyser IVD
The BreathID® Hp Lab System is intended for use to non-invasively measure changes in the 13CO2/ 12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Hp Lab System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp Lab System consists of the appropriate IDkit: Hp™ kit, and the BreathID® Hp device, Auto Sampler and Lab Application
MERIDIAN BIOSCIENCE ISRAEL LTD
VS01082
In Commercial Distribution

  • 07290016923070 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram
  • Height: 10 Inch
  • Width: 15.7 Inch
  • Depth: 18 Inch
  • Weight: 9 Kilogram


  • Infrared spectrometry breath analyser IVD
The BreathID® Hp Lab System is intended for use to non-invasively measure changes in the 13CO2/ 12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Hp Lab System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp Lab System consists of the appropriate IDkit: Hp™ kit, and the BreathID® Hp device, Auto Sampler and Lab Application
MERIDIAN BIOSCIENCE ISRAEL LTD
VS01085
In Commercial Distribution

  • 07290016923063 ()

  • Height: 10 Inch
  • Width: 15.7 Inch
  • Depth: 18 Inch
  • Weight: 9 Kilogram


  • Infrared spectrometry breath analyser IVD
The BreathID® Hp System is intended for use to continually and non-invasively measure changes in the13CO2 /12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Hp System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp System consists of the appropriate IDkit:Hp™ kit and the BreathID® Hp test device.
MERIDIAN BIOSCIENCE ISRAEL LTD
VS01000
In Commercial Distribution

  • 07290016923056 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram
VS01000

  • Infrared spectrometry breath analyser IVD
Ceramill map DRS
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
754472
In Commercial Distribution

  • DIVO7544720 ()
  • DIVO7544721 ()
754472

  • Intraoral optical scanning system
VivaScan Intraoral Scanner
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
740278
In Commercial Distribution

  • DIVO7402780 ()
  • DIVO7402781 ()
740278

  • Intraoral optical scanning system
The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of the teeth and gums to be repaired in the patient's mouth, and provides 3D digital models for CAD/CAM denture design and processing.
Shining 3D Tech Co., Ltd.
Elegant 3
In Commercial Distribution

  • 06970163081779 ()


  • Intraoral optical scanning system
The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of the teeth and gums to be repaired in the patient's mouth, and provides 3D digital models for CAD/CAM denture design and processing.
Shining 3D Tech Co., Ltd.
Aoralscan 2
In Commercial Distribution

  • 06970163080024 ()


  • Intraoral optical scanning system
The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of the teeth and gums to be repaired in the patient's mouth, and provides 3D digital models for CAD/CAM denture design and processing.
Shining 3D Tech Co., Ltd.
Aoralscan 2
In Commercial Distribution

  • 06970163080017 ()


  • Intraoral optical scanning system
iTero Lumina Pro US Mobile upgrade from Element Plus
Align Technology, Inc.
221948
In Commercial Distribution

  • 00816063022442 ()


  • Intraoral optical scanning system
iTero Lumina Pro US Cart upgrade from Element Plus
Align Technology, Inc.
221946
In Commercial Distribution

  • 00816063022428 ()


  • Intraoral optical scanning system
iTero Lumina Pro US DOA Kit cart
Align Technology, Inc.
221971
In Commercial Distribution

  • 00816063022329 ()


  • Intraoral optical scanning system
iTero Lumina Pro Scanning Unit, RMA Package US
Align Technology, Inc.
221925
In Commercial Distribution

  • 00816063022268 ()


  • Intraoral optical scanning system
Intraoral Scanner
Alliedstar Medical Equipment Co., Ltd.
ST 200E
In Commercial Distribution

  • 06973993442222 ()


  • Intraoral optical scanning system
Intraoral Scanner
Alliedstar Medical Equipment Co., Ltd.
NeoScan 2000
In Commercial Distribution

  • 06973993442086 ()
91001

  • Intraoral optical scanning system
No Description
Alliedstar Medical Equipment Co., Ltd.
AS 260
In Commercial Distribution

  • 06973993442048 ()
6583207

  • Intraoral optical scanning system
NeoScan 1000 Intraoral Scanner
Alliedstar Medical Equipment Co., Ltd.
NeoScan 1000
In Commercial Distribution

  • 06973993442031 ()
91000

  • Intraoral optical scanning system
AS 200E – Intraoral Scanner
Alliedstar Medical Equipment Co., Ltd.
AS 200E
In Commercial Distribution

  • 06973993442024 ()
6583202

  • Intraoral optical scanning system
AS 100 Intraoral Scanner
Alliedstar Medical Equipment Co., Ltd.
AS 100
In Commercial Distribution

  • 06973993442017 ()
6583169

  • Intraoral optical scanning system
No Description
Alliedstar Medical Equipment Co., Ltd.
ST 200E Charging Holder
In Commercial Distribution

  • 06973993441584 ()


  • Intraoral optical scanning system
No Description
Alliedstar Medical Equipment Co., Ltd.
NeoScan 2000-Charging Holder
In Commercial Distribution

  • 06973993441263 ()
91042

  • Intraoral optical scanning system
Intraoral scanner holder set
Alliedstar Medical Equipment Co., Ltd.
Holder set
In Commercial Distribution

  • 06973993441096 ()
91020

  • Intraoral optical scanning system
Intraoral scanner S tip
Alliedstar Medical Equipment Co., Ltd.
TP103N
In Commercial Distribution

  • 26973993441069 ()
  • 06973993441065 ()
91013

  • Intraoral optical scanning system
Introral scanner L tip
Alliedstar Medical Equipment Co., Ltd.
TP102N
In Commercial Distribution

  • 06973993441058 ()
  • 26973993441052 ()
91012

  • Intraoral optical scanning system
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