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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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Sterngold Implant System Guided Latch Driver - PUR. - 00841549118968

Used to turn the implant as it is screwed into the bone.
STERNGOLD DENTAL LLC
905793
In Commercial Distribution

  • 00841549118968 ()


  • Surgical screwdriver, reusable

PUR® Implant Driver - Latch - 00841549118104

Used to turn the implant as it is screwed into the bone.
STERNGOLD DENTAL LLC
905287
In Commercial Distribution

  • 00841549118104 ()


  • Surgical screwdriver, reusable

Impla Clean Plastic Implant Instrument Kit - 00014081552204

Set of four double-ended plastic implant instruments. Each instrument is shaped differently.
HAGER WORLDWIDE, INC.
355220
Not in Commercial Distribution

  • 00014081552204 ()


  • Manual dental scaler, reusable

TITAN™ - 10381780258216

The Fin-Lock Drill Guide is used for precision and accuracy when drilling.
Ascension Orthopedics, Inc.
DRG-0926-001
In Commercial Distribution

  • M269DRG09260011 ()
  • 10381780258216 ()

  • 1.25 in L x .960 in W


  • Surgical drill guide, reusable

Ascension® - 10381780247616

Ascension® MCP The MCP X-ray template is used for size assessment.
Ascension Orthopedics, Inc.
TMP-100-00
In Commercial Distribution

  • M269TMP100001 ()
  • 10381780247616 ()

  • NA
TMP-100-00

  • Surgical implant template, reusable

Integra® - 10381780247463

Integra®Surgical Instruments The slap hammer is used to apply force.
Ascension Orthopedics, Inc.
SLP1002519
In Commercial Distribution

  • M269SLP10025191 ()
  • 10381780247463 ()

  • 290 mm L
SLP-1002-519

  • Orthopaedic implant impactor, reusable

Integra® - 10381780246343

Integra®Surgical Instruments The ratchet t-handle is provided with quick connect.
Ascension Orthopedics, Inc.
NR135004J004
In Commercial Distribution

  • M269NR135004J0041 ()
  • 10381780246343 ()

  • 4.5 in L x 3.88 in W
NR135004-J-004

  • Surgical instrument handle, non-torque-limiting

Titan™ - 10381780245476

Titan™ Reverse Shoulder System The handle is used to remove glenospheres.
Ascension Orthopedics, Inc.
HDL096006701
In Commercial Distribution

  • M269HDL0960067011 ()
  • 10381780245476 ()

  • 10.4 in x .255in diameter
HDL-0960-067-01

  • Surgical instrument handle, non-torque-limiting

Integra® - 10381780243991

Integra® Lunate The Lunate Base is designed to contain the instruments.
Ascension Orthopedics, Inc.
CSA71002
In Commercial Distribution

  • M269CSA710021 ()
  • 10381780243991 ()
CSA-710-02

  • Instrument tray, reusable

CAPTURE™ - 10381780242093

CAPTURE™ Cannulated Screw System Smooth K-Wire is used for temporary fixation.
Ascension Orthopedics, Inc.
AW1111
In Commercial Distribution

  • M269AW11111 ()
  • 10381780242093 ()

  • 3.53 in L x .0315 in dia
AW1111

  • Orthopaedic guidewire, reusable
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