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
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M874CB1415030080OTW1 ()


  • Peripheral angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M874CB1415030040OTW1 ()


  • Peripheral angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M874CB1415030020OTW1 ()


  • Peripheral angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M874CB1415025120OTW1 ()


  • Peripheral angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M874CB1415025080OTW1 ()


  • Peripheral angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M874CB1415025040OTW1 ()


  • Peripheral angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M874CB1415025020OTW1 ()


  • Peripheral angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M8744100A20201 ()


  • Coronary angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M8744100A20121 ()


  • Coronary angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M8744100A20081 ()


  • Coronary angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M8744100A20041 ()


  • Coronary angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M8744100A15201 ()


  • Coronary angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M8744100A15121 ()


  • Coronary angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M8744100A15081 ()


  • Coronary angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
A
In Commercial Distribution

  • M8744100A15041 ()
4100A1504

  • Coronary angioplasty balloon catheter, basic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022245 ()

  • Height: 25 Millimeter
  • Outer Diameter: 95 Millimeter
MDDK3740Z25V1

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022238 ()

  • Outer Diameter: 95 Millimeter
  • Height: 22 Millimeter
MDDK3740Z22V1

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022221 ()

  • Height: 18 Millimeter
  • Outer Diameter: 95 Millimeter
MDDK3740Z18V1

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022214 ()

  • Outer Diameter: 95 Millimeter
  • Height: 16 Millimeter
MDDK3740Z16V6

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022207 ()

  • Height: 16 Millimeter
  • Outer Diameter: 95 Millimeter
MDDK3740Z16V5

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022191 ()

  • Outer Diameter: 95 Millimeter
  • Height: 16 Millimeter
MDDK3740Z16V4

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022184 ()

  • Height: 16 Millimeter
  • Outer Diameter: 95 Millimeter
MDDK3740Z16V3

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022177 ()

  • Outer Diameter: 95 Millimeter
  • Height: 16 Millimeter
MDDK3740Z16V2

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022160 ()

  • Height: 16 Millimeter
  • Outer Diameter: 95 Millimeter
MDDK3740Z16V1

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022153 ()

  • Outer Diameter: 95 Millimeter
  • Height: 16 Millimeter
MDDK3740Z16V0

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022146 ()

  • Height: 14 Millimeter
  • Outer Diameter: 95 Millimeter
MDDK3740Z14V6

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022139 ()

  • Outer Diameter: 95 Millimeter
  • Height: 14 Millimeter
MDDK3740Z14V5

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022122 ()

  • Height: 14 Millimeter
  • Outer Diameter: 95 Millimeter
MDDK3740Z14V4

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022115 ()

  • Outer Diameter: 95 Millimeter
  • Height: 14 Millimeter
MDDK3740Z14V3

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022108 ()

  • Height: 14 Millimeter
  • Outer Diameter: 95 Millimeter
MDDK3740Z14V2

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022092 ()

  • Outer Diameter: 95 Millimeter
  • Height: 14 Millimeter
MDDK3740Z14V1

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022085 ()

  • Height: 14 Millimeter
  • Outer Diameter: 95 Millimeter
MDDK3740Z14V0

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1400 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724020746 ()

  • Height: 20 Millimeter
  • Outer Diameter: 100 Millimeter
MDDK 3937HT20 T

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1400 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724020739 ()

  • Height: 18 Millimeter
  • Outer Diameter: 100 Millimeter
MDDK 3937HT18 T

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1400 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724020722 ()

  • Height: 14 Millimeter
  • Outer Diameter: 100 Millimeter
MDDK 3937HT14 T

  • Dental appliance fabrication material, ceramic
The SmartBone is a 3D-printed, patient-specific device that is used to set the Glenoid Intelligent Reusable Instrument (IRI) at the time of surgery. This bone model is a 1-to-1 representation of a specific patient's bony anatomy. The SmartBone is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) for Total Shoulder Arthroplasty (TSA).
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
A
Not in Commercial Distribution

  • 00811813020235 ()

  • Patient-specific
0006-0007-UPI

  • Orthopaedic prosthesis implantation positioning instrument, single-use
Pulmoguard A and Air Tube Kit
S D I DIAGNOSTICS INC
A
In Commercial Distribution

  • B279S29330105001 ()
  • B279S293301050 ()
29-3301-050

  • Pulmonary function testing kit
Bacterial Pulmonary Function Filter
S D I DIAGNOSTICS INC
A
In Commercial Distribution

  • B279S293201200 ()
  • B279S293201050 ()
  • B279S29320105001 ()
29-3201-050

  • Pulmonary function testing filter/mouthpiece
Safe T Check
S D I DIAGNOSTICS INC
A
In Commercial Distribution

  • B279S00017 ()
  • B279S000173 ()
S0001-7

  • Pulmonary function testing kit
Pulmoguard A Filter with Air Tube Kit
S D I DIAGNOSTICS INC
A
In Commercial Distribution

  • B279F066105001 ()
  • B279F0661050 ()
F0661-050

  • Pulmonary function testing kit
Pulmonary Function Bacterial Filter
S D I DIAGNOSTICS INC
A
In Commercial Distribution

  • F0660200 ()
  • B279F0660050 ()
  • B279F066005001 ()
F0660-050

  • Pulmonary function testing filter/mouthpiece
Instrument SB with CombiTorque
E.M.S. Electro Medical Systems S.A.
a
In Commercial Distribution

  • 07613353095482 ()
DS-057D

  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Instrument PL1
E.M.S. Electro Medical Systems S.A.
a
In Commercial Distribution

  • 07613353095468 ()
DS-030HF

  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
PIEZON 707 BIK LED - A-dec
E.M.S. Electro Medical Systems S.A.
a
In Commercial Distribution

  • 07613353089375 ()
FS-435HF

  • Ultrasonic dental scaling/debridement system
Kit Piezon OMS
E.M.S. Electro Medical Systems S.A.
a
In Commercial Distribution

  • 07613353089078 ()
FS-383HF

  • Ultrasonic dental scaling/debridement system
Kit Piezon Scaling
E.M.S. Electro Medical Systems S.A.
a
In Commercial Distribution

  • 07613353089054 ()
FS-382HF

  • Ultrasonic dental scaling/debridement system
PIEZO Implant Tip Set
E.M.S. Electro Medical Systems S.A.
a
In Commercial Distribution

  • 07613353088019 ()
FS-361

  • Ultrasonic dental scaling/debridement system
PIEZO Scaler Tip Set
E.M.S. Electro Medical Systems S.A.
a
In Commercial Distribution

  • 07613353087890 ()
FS-354

  • Ultrasonic dental scaling/debridement system
Instrument PI starter kit
E.M.S. Electro Medical Systems S.A.
a
In Commercial Distribution

  • 07613353086831 ()
FS-295#HF/A/001

  • Ultrasonic dental scaling/debridement system
Instrument ESI starter kit
E.M.S. Electro Medical Systems S.A.
a
In Commercial Distribution

  • 07613353086558 ()
FS-279#HF/A/001

  • Ultrasonic dental scaling/debridement system
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