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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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Tapered Dental Implant 7.0mm in diameter and 20mm in Length
Suncoast Dental, Inc
Tapered/7.0x20
Not in Commercial Distribution

  • 00083208070204 ()

  • Tapered Dental Implant 7.0mm in diameter and 20mm in Length
  • Outer Diameter: 7 Millimeter
  • Height: 20 Millimeter
IT7.0 x 20mm

  • Screw endosteal dental implant, two-piece
5.0 mm Neck Diameter x 9 mm Length. Integrity Dental Implant
Suncoast Dental, Inc
ITI 5.0 x 9mm
Not in Commercial Distribution

  • 00083208450099 ()

  • Integrity Dental Implant 5.0mm in diameter and 9mm in length
  • Outer Diameter: 5 Millimeter
  • Height: 9 Millimeter
ITI 5.0 x 09

  • Screw endosteal dental implant, two-piece
4.5 mm Neck Diameter x 9 mm Length. Integrity Dental Implant
Suncoast Dental, Inc
ITI 4.5 x 9mm
Not in Commercial Distribution

  • 00083208445095 ()

  • Outer Diameter: 4.5 Millimeter
  • Integrity Dental Implant 4.5mm in diameter and 9mm in length
  • Height: 9 Millimeter
ITI 4.5 x 09

  • Screw endosteal dental implant, two-piece
4.0 mm Neck Diameter x 9 mm Length. Integrity Dental Implant
Suncoast Dental, Inc
ITI 4.0 x 9mm
Not in Commercial Distribution

  • 00083208440090 ()

  • Outer Diameter: 4 Millimeter
  • Integrity Dental Implant 4.0mm in diameter and 9mm in length
  • Height: 9 Millimeter
ITI 4.0 x 09

  • Screw endosteal dental implant, two-piece
3.7mm Neck Diameter x 09mm Length. Integrity Dental Implant
Suncoast Dental, Inc
ITI 3.7 x 9mm
Not in Commercial Distribution

  • 00083208437090 ()

  • Height: 9 Millimeter
  • Outer Diameter: 3.7 Millimeter
  • Integrity Dental Implant 3.7mm in diameter and 9mm in length
ITI 3.7 x 09

  • Screw endosteal dental implant, two-piece
Integra® External Fixation System The ExFix Tray 5 Top locks onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
12227010
In Commercial Distribution

  • M269122270101 ()
  • 10381780248224 ()

  • 21.15 L x 10.62 in W x 1.69 in H
12227010

  • Instrument tray, reusable
Titan™ Reverse Shoulder System The head cutting template has a right orientation. It is used for head resection.
Ascension Orthopedics, Inc.
TMP096001R
In Commercial Distribution

  • M269TMP096001R1 ()
  • 10381780247609 ()

  • 3.04 in L x 1.11 in W; 142 degree angle
TMP-0960-001R

  • Surgical implant template, reusable
Titan™ Reverse Shoulder System The head cutting template has a left orientation. It is used for head resection.
Ascension Orthopedics, Inc.
TMP096001L
In Commercial Distribution

  • M269TMP096001L1 ()
  • 10381780247593 ()

  • 3.04 in L x 1.11 in W; 142 degree angle
TMP-0960-001L

  • Surgical implant template, reusable
Movement® Great Toe System Proximal Phalanx Surface Reamer Sz. 30/4 The Movement Great Toe proximal phalanx surface reamer is used to compress and/or remove bone to create a cavity of proper shape and size for device press fit.
Ascension Orthopedics, Inc.
PSR-890-30/40
In Commercial Distribution

  • M269PSR89030401 ()
  • 10381780246701 ()

  • Size 30/40; 3.12 in L x .830 in dia
PSR8903040

  • Bone-resection orthopaedic reamer, reusable
Movement® Great Toe System Proximal Phalanx Surface Reamer Sz. 10/2 The Movement Great Toe proximal phalanx surface reamer is used to compress and/or remove bone to create a cavity of proper shape and size for device press fit.
Ascension Orthopedics, Inc.
PSR-890-10/20
In Commercial Distribution

  • M269PSR89010201 ()
  • 10381780246695 ()

  • Size 10/20; 3.12 in L x .720 in dia
PSR8901020

  • Bone-resection orthopaedic reamer, reusable
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