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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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CAPTURE™ - 10381780244233

CAPTURE™ High Torque Screw System The cannulated torx driver is used in conjunction with the Capture High Torque Screw system.
Ascension Orthopedics, Inc.
CTD-5000-504-070
In Commercial Distribution

  • M269CTD50005040701 ()
  • 10381780244233 ()

  • 203.2 mm L
TD5000504070

  • Surgical screwdriver, reusable

Cadence™ - 10381780240303

Cadence Tibial Impactor Handle is attached to the Tibial Impactor Tip which is used in the insertion of the Tibial Tray.
Ascension Orthopedics, Inc.
10203136
Not in Commercial Distribution

  • M268102031361 ()
  • 10381780240303 ()

  • 5.16in Lx .425in diameter


  • Orthopaedic implant/instrument assembling device

Surgical Direct - B382SD81411150

4.8mm 10' Autoclavable Fiber Light Cable, Light Source Type: Wolf, Stryker X8000..Scope Type: Wolf, Large Snap in Fitting, without Clip
Surgical Direct, Inc.
SD8141115
In Commercial Distribution

  • B382SD81411150 ()

  • Length: 10 Feet
  • Outer Diameter: 4.8 Millimeter
SD8141115

  • Fibreoptic light cable

Quick Cure - D798QCPT1

Quick Cure is intended for use as a light cure bracket adhesive. 5gm. of Quick Cure adhesive paste in syringe tips
RELIANCE ORTHODONTIC PRODUCTS INC
QCPT
Not in Commercial Distribution

  • D798QCPT1 ()
  • D798QCPT0 ()
QCPT

  • Orthodontic bracket adhesive

Renew - D798RSBL0

The Renew® Finishing System is intended for use in the removal of composite paste after debonding. Size 118 Long Shank
RELIANCE ORTHODONTIC PRODUCTS INC
RSBL
In Commercial Distribution

  • D798RSBL0 ()
RSBL

  • Carbide dental bur, reusable

Renew - D798RSB8150

The Renew® Finishing System is intended for use in the removal of composite paste after debonding. Size 815, Lingual Bur
RELIANCE ORTHODONTIC PRODUCTS INC
RSB815
Not in Commercial Distribution

  • D798RSB8150 ()
RSB815

  • Carbide dental bur, reusable

Renew - D798RSB815

The Renew® Finishing System is intended for use in the removal of composite paste after debonding. Size 815, Lingual Bur
RELIANCE ORTHODONTIC PRODUCTS INC
RSB815
Not in Commercial Distribution

  • D798RSB815 ()
RSB815

  • Carbide dental bur, reusable

Renew - D798RSB0

The Renew® Finishing System is intended for use in the removal of composite paste after debonding. Size 118 Short shank.
RELIANCE ORTHODONTIC PRODUCTS INC
RSB
In Commercial Distribution

  • D798RSB0 ()
RSB

  • Carbide dental bur, reusable

KC 10 Tubing Separator - M996KC100

KC 10 Tubing Separator separates large bore tubing from small bore tubing. Made of silicone rubber. Reusable. Made in the USA.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 10
In Commercial Distribution

  • M996KC106 ()
  • M996KC100 ()
  • M996KC102 ()
KC 10

  • Breathing circuit tube holder

ACHILLON® - 10381780043300

The needle for the Achillon® suture system is used to suture the Achilles tendon parts in acute Achilles tendon rupture.
NEWDEAL
119720ND
In Commercial Distribution

  • M248119720ND1 ()
  • 10381780043300 ()
  • 00381780043303 ()
119720ND

  • Suturing needle, single-use
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