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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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XCP-ORA® Sirona XIOS Plus. Contains: XCP-DS® Kodak 8 Vertical Anterior Biteblocks, XCP-DS® Kodak 8 Horizontal Posterior Biteblocks, XCP-DS® Kodak 8 Horizontal Bitewings with Biteblock, Schick Elite 8 Vertical Bitewings, XCP-ORA® Arm and Ring, 50 Bulk Sensor Covers.
Dentsply International Inc.
552160
Not in Commercial Distribution

  • D0035521601 ()


  • Dental x-ray film holder, reusable
  • Medical equipment/instrument drape, single-use
XCP-ORA® Schick CDR Kit. Contains: 1 XCP-ORA® Arm and Ring. XCP-DS® 8 Horizontal Bitewings, 8 Vertical Bitewings. XCP-DS® 8 Vertical Anterior Biteblocks. XCP-DS® 8 Horizontal Posterior Biteblocks. 50 Bulk Sensor Covers.
Dentsply International Inc.
551971
Not in Commercial Distribution

  • D0035519711 ()


  • Dental x-ray film holder, reusable
  • Medical equipment/instrument drape, single-use
XCP-DS FIT® Universal Sensor Holder. Contains: Snap-A-Ray Pack, 2 XCP-ORA® Arm and Rings, 6 Biteblocks (4 Anterior, 2 Posterior), XCP 14 Bitewings (7 Vertical, 6 Horizontal, 1 Suresoft), 50 Universal Sensor Covers.
Dentsply International Inc.
549975
Not in Commercial Distribution

  • D0035499751 ()
549975

  • Dental x-ray film holder, reusable
  • Medical equipment/instrument drape, single-use
XCP-DS FIT® Universal Sensor Holder. Contains: 1 XCP-ORA® Arm & Ring, 6 Biteblocks, 6 Bitewings (3 Vertical, 3 Horizontal), 50 Universal Sensor Covers.
Dentsply International Inc.
549971
Not in Commercial Distribution

  • D0035499711 ()
549971

  • Dental x-ray film holder, reusable
  • Medical equipment/instrument drape, single-use
par needle holder, tungsten carbide, serrated jaws, delicate, 5" (12.7 cm)
NOVO SURGICAL, INC.
G4351-51
In Commercial Distribution

  • 00842331183041 ()
G4351-51

  • Surgical instrument interim-placement holder, single-use
sarot needle holder, one jaw fenestrated, 7 1/8" (18.0 cm)
NOVO SURGICAL, INC.
G2133-29
In Commercial Distribution

  • 00842331182938 ()
G2133-29

  • Surgical instrument interim-placement holder, single-use
IN SITU BENDER RIGHT
ALPHATEC SPINE, INC.
87061
In Commercial Distribution

  • 00844856070134 ()


  • Manual orthopaedic bender, reusable
IN SITU BENDER LEFT
ALPHATEC SPINE, INC.
87060
In Commercial Distribution

  • 00844856070127 ()


  • Manual orthopaedic bender, reusable
FRENCH ROD BENDER
ALPHATEC SPINE, INC.
87016
In Commercial Distribution

  • 00844856069633 ()


  • Manual orthopaedic bender, reusable
PLATE BENDER
Evolution Spine LLC
100-A038
In Commercial Distribution

  • 00195860015452 ()
100-A038

  • Manual orthopaedic bender, reusable
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