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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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Stage-1 - D768S1805K0

Placement Head
KEYSTONE DENTAL, INC.
S1805K
In Commercial Distribution

  • D768S1805K0 ()


  • Surgical screwdriver, reusable

Stage-1 - D768S160101K0

Placement Head
KEYSTONE DENTAL, INC.
S1601-01K
In Commercial Distribution

  • D768S160101K0 ()


  • Surgical screwdriver, reusable

Blue Sky Bio, LLC. - 00815131028928

BIO | Trilobe Implant Driver 5.0mm Short
BLUE SKY BIO LLC
DJT50S
In Commercial Distribution

  • 00815131028928 ()


  • Surgical torque wrench adaptor

Blue Sky Bio, LLC. - 00815131028911

BIO | Trilobe Implant Driver 5.0mm Long
BLUE SKY BIO LLC
DJT50L
In Commercial Distribution

  • 00815131028911 ()


  • Surgical torque wrench adaptor

Blue Sky Bio, LLC. - 00815131028898

BIO | Trilobe Implant Driver 4.3mm Long
BLUE SKY BIO LLC
DJT43L
In Commercial Distribution

  • 00815131028898 ()


  • Surgical torque wrench adaptor

Blue Sky Bio, LLC. - 00815131028904

BIO | Trilobe Implant Driver 4.3mm Short
BLUE SKY BIO LLC
DJT43S
In Commercial Distribution

  • 00815131028904 ()


  • Surgical torque wrench adaptor

Blue Sky Bio, LLC. - 00815131028881

BIO | Trilobe Implant Driver 3.5mm Short
BLUE SKY BIO LLC
DJT35S
In Commercial Distribution

  • 00815131028881 ()


  • Surgical torque wrench adaptor

Blue Sky Bio, LLC. - 00815131028874

BIO | Trilobe Implant Driver 3.5mm Long
BLUE SKY BIO LLC
DJT35L
In Commercial Distribution

  • 00815131028874 ()


  • Surgical torque wrench adaptor

Arthrex® - 00888867087880

DRILL, 9.5MM CANNULATED
ARTHREX, INC.
AR-1218-95
In Commercial Distribution

  • 00888867087880 ()
AR-1218-95

  • Cannulated surgical drill bit, single-use

Arthrex® - 00888867087873

DRILL, 9MM CANNULATED
ARTHREX, INC.
AR-1218-90
In Commercial Distribution

  • 00888867087873 ()
AR-1218-90

  • Cannulated surgical drill bit, single-use
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