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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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Drill Bit, 3.2 mm Diameter
A.B. DENTAL DEVICES LTD
TD-3.2
In Commercial Distribution

  • 07290107274999 ()
TD-3.2

  • Fixture/appliance dental drill bit, reusable
Pilot Drill Bit, 2 mm Diameter
A.B. DENTAL DEVICES LTD
TPD-2
In Commercial Distribution

  • 07290107274982 ()
TPD-2

  • Fixture/appliance dental drill bit, reusable
Marker Drill Bit, 1.9 mm Diameter
A.B. DENTAL DEVICES LTD
TMD-1.9
In Commercial Distribution

  • 07290107274975 ()
TMD-1.9

  • Fixture/appliance dental drill bit, reusable
Tissue punch driver
A.B. DENTAL DEVICES LTD
T17
In Commercial Distribution

  • 17290107274934 ()
  • 07290107274937 ()
T17

  • Surgical mallet
Mallet
A.B. DENTAL DEVICES LTD
T11
In Commercial Distribution

  • 17290107274903 ()
  • 07290107274906 ()
T11

  • Surgical mallet
Handle
A.B. DENTAL DEVICES LTD
T10
In Commercial Distribution

  • 17290107274897 ()
  • 07290107274890 ()
T10

  • Surgical mallet
Depth Gauge
A.B. DENTAL DEVICES LTD
T9
In Commercial Distribution

  • 17290107274880 ()
  • 07290107274883 ()
T9

  • Dental implantation depth/angle gauge, reusable
Ratchet-Torque Combination
A.B. DENTAL DEVICES LTD
T8c-10-40
In Commercial Distribution

  • 17290107274873 ()
  • 07290107274876 ()
T8c-10-40

  • Dental torque wrench
Ratchet Hex Driver for Implant, 2.4 mm Diameter, 9 mm length
A.B. DENTAL DEVICES LTD
T3-2.4,9
In Commercial Distribution

  • 07290107274753 ()
T3-2.4,9

  • Surgical screwdriver, reusable
Ratchet Hex Driver for Implant, 2 mm Diameter, 18 mm length
A.B. DENTAL DEVICES LTD
T3-2,18
In Commercial Distribution

  • 07290107274746 ()
T3-2,18

  • Surgical screwdriver, reusable
Ratchet Hex Driver for Implant
A.B. DENTAL DEVICES LTD
T3-2,9
In Commercial Distribution

  • 17290107274736 ()
  • 07290107274739 ()
T3-2,9

  • Surgical screwdriver, reusable
Hand Hex Driver for P6
A.B. DENTAL DEVICES LTD
T2-1.8,15
In Commercial Distribution

  • 17290107274729 ()
  • 07290107274722 ()
T2-1.8,15

  • Surgical screwdriver, reusable
Ratchet Hex Driver for P6
A.B. DENTAL DEVICES LTD
T1-1.8,15
In Commercial Distribution

  • 17290107274682 ()
  • 07290107274685 ()
T1-1.8,15

  • Surgical screwdriver, reusable
Ratchet Hex Driver for P6
A.B. DENTAL DEVICES LTD
T1-1.8,9
In Commercial Distribution

  • 17290107274675 ()
  • 07290107274678 ()
T1-1.8,9

  • Surgical screwdriver, reusable
Ratchet Hex Driver for Abutment, 1.25 mm Diameter, 15 mm length
A.B. DENTAL DEVICES LTD
T1-1.2,15
In Commercial Distribution

  • 07290107274661 ()
  • 17290107274705 ()
T1-1.2,15

  • Surgical screwdriver, reusable
Ratchet Hex Driver for Abutment, 1.25 mm Diameter, 9 mm length
A.B. DENTAL DEVICES LTD
T1-1.2,9
In Commercial Distribution

  • 07290107274654 ()
T1-1.2,9

  • Surgical screwdriver, reusable
Analog for P24
A.B. DENTAL DEVICES LTD
D1-P24
In Commercial Distribution

  • 17290107274255 ()
  • 07290107274258 ()
D1-P24

  • Dental implant analog
OrthoGrid Hip Preservation 3.0 non-invasive software system that provides image analysis tools for Hip Preservation.
Orthogrid Systems, Inc.
4015-915-501
In Commercial Distribution

  • 00860003424810 ()


  • Orthopaedic fluoroscopic grid software
Insulin Titration App
Sanofi-Aventis Deutschland GmbH
2.x.x
Not in Commercial Distribution


  • No size - Software as a Medical Device
N/A

  • Clinical management support software
OrthoGrid Hip AI for non-invasive software system that provides image analysis tools for Total Hip Replacement
Orthogrid Systems, Inc.
1015-915-505
In Commercial Distribution

  • 00860003424834 ()


  • Orthopaedic fluoroscopic grid software
OrthoGrid Hip 3.0 for non-invasive software system that provides image analysis tools for Total Hip Replacement
Orthogrid Systems, Inc.
1015-915-504
In Commercial Distribution

  • 00860003424803 ()


  • Orthopaedic fluoroscopic grid software
The Test of Variables of Attention (T.O.V.A.) software is a computerized assessment of attention and inhibitory control that runs on most Windows and Mac-based computers. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
TOVA COMPANY, THE
Software
In Commercial Distribution

  • 00862290000326 ()


  • Cognitive assessment software
No Description
FIM MEDICAL
Software
In Commercial Distribution

  • 03760253450577 ()


  • Pulmonary function analysis system, adult
No Description
FIM MEDICAL
Software
Not in Commercial Distribution

  • 03760253450157 ()


  • Pulmonary function analysis system, adult
SUPPORT FOR CUTTING TOOLS
Synthes GmbH
68.000.007.98
In Commercial Distribution

  • 10886982251343 ()
  • 10887587058801 ()
  • H98068000007980 ()
6800000798

  • Surgical instrument/implant rack
LINX Esophagus Sizing Tools
Torax Medical, Inc.
LSSUS
In Commercial Distribution

  • 00855106005219 ()
  • 00855106005226 ()
LSSUS

  • Gastro-oesophageal antireflux prosthesis
ASSEMBLY, INSTALLATION VERIFICATION TOOLS
THINK SURGICAL, INC.
102940
In Commercial Distribution

  • M9461029400 ()


  • Robotic surgical arm system
HM3 Surgical Hand Tools
Thoratec Corporation
10002222US
In Commercial Distribution

  • 00813024013259 ()
10002222US

  • Cardiothoracic surgical procedure kit, non-medicated, reusable
ACCESSORY 3550-06 TUNNELING TOOLS
MEDTRONIC, INC.
3550-06
Not in Commercial Distribution

  • 10681490078013 ()


  • Subcutaneous tunneller, single-use
REMOVAL TOOLS ULTRA MINI
DTI IMPLANT SISTEMLERI SANAYI TICARET ANONIM SIRKETI
SURGICAL KIT
In Commercial Distribution

  • 08680671496399 ()
DTIDRTOUM

  • Surgical screwdriver, reusable
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