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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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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
"PRTI - is a self-tapping titanium dental implant, pronounced conical shape, with variable thread, with internal Hex2.43 connection. Implants are made of medical titanium alloy Ti6Al4V ASTM-136. Implants are available in diameter 3.3; 3.75; 4.2; 5.0; 6.0 mm in diameter and length 5; 6; 7; 8; 10; 11.5; 13; 16mm. The outer surface of the implant undergoes double treatment (sandblasting and acid treatment). The texture of the outer surface of the implant has micropores of 1-4 microns in size and macropores of 30-40 microns in size. The external thread of the implant has a double spiral shape. The internal connection of the implant - a internal hexagon 2.43 mmd and internal thread 1-72 UNF for all diameters. Implant complete with disposable carrier-441113 (441113S for 5-7mm short implants) and titanium cover screw-720638 (720638S for 5-7mm short implants). Used in all types of jaws. Recommended for bones of type D1, D2, D3. Implant areas - all parts of the upper and lower jaw. Indications - two-stage implantation."
DMI INNOVATIVE MEDICAL TECHNOLOGY LTD
A
Not in Commercial Distribution

  • 07290112765901 ()

  • Length: 11.5 Millimeter
  • Outer Diameter: 3.3 Millimeter
  • Internal Hex 2.43 mmd
111133

  • Screw endosteal dental implant, two-piece
"PRTI - is a self-tapping titanium dental implant, pronounced conical shape, with variable thread, with internal Hex2.43 connection. Implants are made of medical titanium alloy Ti6Al4V ASTM-136. Implants are available in diameter 3.3; 3.75; 4.2; 5.0; 6.0 mm in diameter and length 5; 6; 7; 8; 10; 11.5; 13; 16mm. The outer surface of the implant undergoes double treatment (sandblasting and acid treatment). The texture of the outer surface of the implant has micropores of 1-4 microns in size and macropores of 30-40 microns in size. The external thread of the implant has a double spiral shape. The internal connection of the implant - a internal hexagon 2.43 mmd and internal thread 1-72 UNF for all diameters. Implant complete with disposable carrier-441113 (441113S for 5-7mm short implants) and titanium cover screw-720638 (720638S for 5-7mm short implants). Used in all types of jaws. Recommended for bones of type D1, D2, D3. Implant areas - all parts of the upper and lower jaw. Indications - two-stage implantation."
DMI INNOVATIVE MEDICAL TECHNOLOGY LTD
A
Not in Commercial Distribution

  • 07290112765871 ()

  • Length: 10 Millimeter
  • Outer Diameter: 3.3 Millimeter
  • H2.43mm
111033

  • Screw endosteal dental implant, two-piece
"PRTI - is a self-tapping titanium dental implant, pronounced conical shape, with variable thread, with internal Hex2.43 connection. Implants are made of medical titanium alloy Ti6Al4V ASTM-136. Implants are available in diameter 3.3; 3.75; 4.2; 5.0; 6.0 mm in diameter and length 5; 6; 7; 8; 10; 11.5; 13; 16mm. The outer surface of the implant undergoes double treatment (sandblasting and acid treatment). The texture of the outer surface of the implant has micropores of 1-4 microns in size and macropores of 30-40 microns in size. The external thread of the implant has a double spiral shape. The internal connection of the implant - a internal hexagon 2.43 mmd and internal thread 1-72 UNF for all diameters. Implant complete with disposable carrier-441113 (441113S for 5-7mm short implants) and titanium cover screw-720638 (720638S for 5-7mm short implants). Used in all types of jaws. Recommended for bones of type D1, D2, D3. Implant areas - all parts of the upper and lower jaw. Indications - two-stage implantation."
DMI INNOVATIVE MEDICAL TECHNOLOGY LTD
A
Not in Commercial Distribution

  • 07290112760081 ()

  • Length: 11.5 Millimeter
  • Outer Diameter: 3.75 Millimeter
  • Device Size Tex2.43
111137

  • Screw endosteal dental implant, two-piece
"PRTI - is a self-tapping titanium dental implant, pronounced conical shape, with variable thread, with internal Hex2.43 connection. Implants are made of medical titanium alloy Ti6Al4V ASTM-136. Implants are available in diameter 3.3; 3.75; 4.2; 5.0; 6.0 mm in diameter and length 5; 6; 7; 8; 10; 11.5; 13; 16mm. The outer surface of the implant undergoes double treatment (sandblasting and acid treatment). The texture of the outer surface of the implant has micropores of 1-4 microns in size and macropores of 30-40 microns in size. The external thread of the implant has a double spiral shape. The internal connection of the implant - a internal hexagon 2.43 mmd and internal thread 1-72 UNF for all diameters. Implant complete with disposable carrier-441113 (441113S for 5-7mm short implants) and titanium cover screw-720638 (720638S for 5-7mm short implants). Used in all types of jaws. Recommended for bones of type D1, D2, D3. Implant areas - all parts of the upper and lower jaw. Indications - two-stage implantation."
DMI INNOVATIVE MEDICAL TECHNOLOGY LTD
A
Not in Commercial Distribution

  • 07290112760067 ()

  • Length: 8 Millimeter
  • Outer Diameter: 5 Millimeter
  • Internal hex 2.43 mmd
111050

  • Screw endosteal dental implant, two-piece
"PRTI - is a self-tapping titanium dental implant, pronounced conical shape, with variable thread, with internal Hex2.43 connection. Implants are made of medical titanium alloy Ti6Al4V ASTM-136. Implants are available in diameter 3.3; 3.75; 4.2; 5.0; 6.0 mm in diameter and length 5; 6; 7; 8; 10; 11.5; 13; 16mm. The outer surface of the implant undergoes double treatment (sandblasting and acid treatment). The texture of the outer surface of the implant has micropores of 1-4 microns in size and macropores of 30-40 microns in size. The external thread of the implant has a double spiral shape. The internal connection of the implant - a internal hexagon 2.43 mmd and internal thread 1-72 UNF for all diameters. Implant complete with disposable carrier-441113 (441113S for 5-7mm short implants) and titanium cover screw-720638 (720638S for 5-7mm short implants). Used in all types of jaws. Recommended for bones of type D1, D2, D3. Implant areas - all parts of the upper and lower jaw. Indications - two-stage implantation."
DMI INNOVATIVE MEDICAL TECHNOLOGY LTD
A
Not in Commercial Distribution

  • 07290112760043 ()

  • Outer Diameter: 3.75 Millimeter
  • Length: 10 Millimeter
  • H2.43
111037

  • Screw endosteal dental implant, two-piece
"PRTI - is a self-tapping titanium dental implant, pronounced conical shape, with variable thread, with internal Hex2.43 connection. Implants are made of medical titanium alloy Ti6Al4V ASTM-136. Implants are available in diameter 3.3; 3.75; 4.2; 5.0; 6.0 mm in diameter and length 5; 6; 7; 8; 10; 11.5; 13; 16mm. The outer surface of the implant undergoes double treatment (sandblasting and acid treatment). The texture of the outer surface of the implant has micropores of 1-4 microns in size and macropores of 30-40 microns in size. The external thread of the implant has a double spiral shape. The internal connection of the implant - a internal hexagon 2.43 mmd and internal thread 1-72 UNF for all diameters. Implant complete with disposable carrier-441113 (441113S for 5-7mm short implants) and titanium cover screw-720638 (720638S for 5-7mm short implants). Used in all types of jaws. Recommended for bones of type D1, D2, D3. Implant areas - all parts of the upper and lower jaw. Indications - two-stage implantation."
DMI INNOVATIVE MEDICAL TECHNOLOGY LTD
A
Not in Commercial Distribution

  • 07290112760036 ()

  • Length: 8 Millimeter
  • Outer Diameter: 6 Millimeter
  • H2.43mm
110860

  • Screw endosteal dental implant, two-piece
"PRTI - is a self-tapping titanium dental implant, pronounced conical shape, with variable thread, with internal Hex2.43 connection. Implants are made of medical titanium alloy Ti6Al4V ASTM-136. Implants are available in diameter 3.3; 3.75; 4.2; 5.0; 6.0 mm in diameter and length 5; 6; 7; 8; 10; 11.5; 13; 16mm. The outer surface of the implant undergoes double treatment (sandblasting and acid treatment). The texture of the outer surface of the implant has micropores of 1-4 microns in size and macropores of 30-40 microns in size. The external thread of the implant has a double spiral shape. The internal connection of the implant - a internal hexagon 2.43 mmd and internal thread 1-72 UNF for all diameters. Implant complete with disposable carrier-441113 (441113S for 5-7mm short implants) and titanium cover screw-720638 (720638S for 5-7mm short implants). Used in all types of jaws. Recommended for bones of type D1, D2, D3. Implant areas - all parts of the upper and lower jaw. Indications - two-stage implantation."
DMI INNOVATIVE MEDICAL TECHNOLOGY LTD
A
Not in Commercial Distribution

  • 07290112760029 ()

  • Length: 8 Millimeter
  • Outer Diameter: 5 Millimeter
  • Hex 2.43 mmd
110850

  • Screw endosteal dental implant, two-piece
"PRTI - is a self-tapping titanium dental implant, pronounced conical shape, with variable thread, with internal Hex2.43 connection. Implants are made of medical titanium alloy Ti6Al4V ASTM-136. Implants are available in diameter 3.3; 3.75; 4.2; 5.0; 6.0 mm in diameter and length 5; 6; 7; 8; 10; 11.5; 13; 16mm. The outer surface of the implant undergoes double treatment (sandblasting and acid treatment). The texture of the outer surface of the implant has micropores of 1-4 microns in size and macropores of 30-40 microns in size. The external thread of the implant has a double spiral shape. The internal connection of the implant - a internal hexagon 2.43 mmd and internal thread 1-72 UNF for all diameters. Implant complete with disposable carrier-441113 (441113S for 5-7mm short implants) and titanium cover screw-720638 (720638S for 5-7mm short implants). Used in all types of jaws. Recommended for bones of type D1, D2, D3. Implant areas - all parts of the upper and lower jaw. Indications - two-stage implantation."
DMI INNOVATIVE MEDICAL TECHNOLOGY LTD
A
Not in Commercial Distribution

  • 07290112760012 ()

  • Length: 8 Millimeter
  • Outer Diameter: 4.2 Millimeter
  • Internal Hex 2.43 mmd
110842

  • Screw endosteal dental implant, two-piece
PRTI - is a self-tapping titanium dental implant, pronounced conical shape, with variable thread, with internal Hex2.43 connection. Implants are made of medical titanium alloy Ti6Al4V ASTM-136. Implants are available in diameter 3.3; 3.75; 4.2; 5.0; 6.0 mm in diameter and length 5; 6; 7; 8; 10; 11.5; 13; 16mm. The outer surface of the implant undergoes double treatment (sandblasting and acid treatment). The texture of the outer surface of the implant has micropores of 1-4 microns in size and macropores of 30-40 microns in size. The external thread of the implant has a double spiral shape. The internal connection of the implant - a internal hexagon 2.43 mmd and internal thread 1-72 UNF for all diameters. Implant complete with disposable carrier-441113 (441113S for 5-7mm short implants) and titanium cover screw-720638 (720638S for 5-7mm short implants). Used in all types of jaws. Recommended for bones of type D1, D2, D3. Implant areas - all parts of the upper and lower jaw. Indications - two-stage implantation.
DMI INNOVATIVE MEDICAL TECHNOLOGY LTD
A
Not in Commercial Distribution

  • 07290112760005 ()

  • Outer Diameter: 3.75 Millimeter
  • Length: 8 Millimeter
110837

  • Screw endosteal dental implant, two-piece
A device used to mix the powder and liquid in application capsules intended for use in dental treatments.
E.M.S. Electro Medical Systems (Hangzhou)Co.,Ltd.
A
In Commercial Distribution

  • 06971503860788 ()
Y200F6D490 9050

  • Dental amalgam mixer
ShangRing Male Circumcision Device Self-locking
Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd.
A
In Commercial Distribution

  • 26939550822368 ()
  • 16939550822361 ()
  • 86939550822360 ()


  • Surgical penis clamp, single-use
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450845967 ()

  • Stent Graft Diameter (mm)-9 mm
  • Delivery Profile (French)-11F
  • Catheter Working Length (cm)-80 cm
  • Stent Graft Length (mm)-125 mm
WRAP-S09125

  • Central/peripheral venous endovascular stent-graft
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450845950 ()

  • Catheter Working Length (cm)-80 cm
  • Stent Graft Diameter (mm)-9 mm
  • Delivery Profile (French)-11F
  • Stent Graft Length (mm)-100 mm
WRAP-S09100

  • Central/peripheral venous endovascular stent-graft
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450845936 ()

  • Stent Graft Length (mm)-50 mm
  • Stent Graft Diameter (mm)-9 mm
  • Catheter Working Length (cm)-80 cm
  • Delivery Profile (French)-10F
WRAP-S09050

  • Central/peripheral venous endovascular stent-graft
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450845905 ()

  • Stent Graft Length (mm)-125 mm
  • Delivery Profile (French)-10F
  • Stent Graft Diameter (mm)-8 mm
  • Catheter Working Length (cm)-80 cm
WRAP-S08125

  • Central/peripheral venous endovascular stent-graft
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450845899 ()

  • Delivery Profile (French)-10F
  • Stent Graft Length (mm)-100 mm
  • Stent Graft Diameter (mm)-8 mm
  • Catheter Working Length (cm)-80 cm
WRAP-S08100

  • Central/peripheral venous endovascular stent-graft
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450845882 ()

  • Catheter Working Length (cm)-80 cm
  • Stent Graft Length (mm)-75 mm
  • Stent Graft Diameter (mm)-8 mm
  • Delivery Profile (French)-9F
WRAP-S08075

  • Central/peripheral venous endovascular stent-graft
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450845875 ()

  • Stent Graft Diameter (mm)-8 mm
  • Catheter Working Length (cm)-80 cm
  • Delivery Profile (French)-9F
  • Stent Graft Length (mm)-50 mm
WRAP-S08050

  • Central/peripheral venous endovascular stent-graft
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450845844 ()

  • Delivery Profile (French)-9F
  • Stent Graft Length (mm)-75 mm
  • Catheter Working Length (cm)-80 cm
  • Stent Graft Diameter (mm)-7 mm
WRAP-S07075

  • Central/peripheral venous endovascular stent-graft
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