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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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APEX Knee System - 00841690190370

4 in 1 Revision AP Cutting Block Size 6/5+
Omni Life Science, Inc.
KS-67006
In Commercial Distribution

  • 00841690190370 ()
KS-67006

  • Joint prosthesis implantation kit, reusable

A. Titan Instruments - 00841685104498

PFI 15 Gold tip Plastic filling instrument in 44 handle
A. TITAN INSTRUMENTS, INC.
PFI 15 Gold 44
In Commercial Distribution

  • 00841685104498 ()


  • Dental restoration carver, resin

Novo Surgical Inc. - 00842331142611

polk finger goniometer, graduated in mm & inches, 6" (15.2 cm)
NOVO SURGICAL, INC.
G5549-41
In Commercial Distribution

  • 00842331142611 ()
G5549-41

  • Manual goniometer

Panetti septum knife - 04250676723284

Luer-Lock, suction hole in angle 45 °, 5.0 mm, 16.5 cm
Spiggle & Theis Medizintechnik GmbH
20-001-15
In Commercial Distribution

  • 04250676723284 ()
20-001-15

  • ENT suction dissector

Panetti suction separator - 04250676700841

45°, 2.5 mm, 13 cm, Luer-Lock suction hole in angle
Spiggle & Theis Medizintechnik GmbH
10-808-12
In Commercial Distribution

  • 04250676700841 ()
10-808-12

  • ENT suction dissector

ELMED - 00842180138667

ELMED BIPOLAR FORCEPS, IN MALIS STYLE, 5 T STR 5"
ELMED INCORPORATED
5970-05D
In Commercial Distribution

  • 00842180138667 ()
5970-05D

  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

TRU® RP Implant Driver - 00841549118135

Wrench - Short. For use in driving Regular Platform TRU Implants.
STERNGOLD DENTAL LLC
905321
In Commercial Distribution

  • 00841549118135 ()


  • Surgical screwdriver, reusable

TRU® NP Implant Drive - 00841549118128

Wrench - Short. For use in driving Narrow Platform TRU Implants.
STERNGOLD DENTAL LLC
905320
In Commercial Distribution

  • 00841549118128 ()


  • Surgical screwdriver, reusable

Sales Rep/Virtual Demo Kit - D9499000312

Convenience kit of Bioclear products used in posterior dental restorations.
Bioclear Matrix Systems
Sales Rep/Virtual Demo Kit
In Commercial Distribution

  • D9499000312 ()


  • Dental matrix band kit
  • Dental wedge, single-use
  • Dental matrix band retainer
  • Dressing/utility forceps, scissors-like, reusable
  • Manual non-rotary dental instrument handle
  • Dental implantation depth/angle gauge, reusable
  • Dental restoration carver, multiple-material
  • Dental surgical probe, reusable

Evolve All-in-One Select Kit - D9498271712

Convenience kit of Bioclear products used in posterior dental restorations.
Bioclear Matrix Systems
Full
In Commercial Distribution

  • D9498271712 ()


  • Dental matrix band kit
  • Dental wedge, single-use
  • Dental matrix band retainer
  • Dressing/utility forceps, scissors-like, reusable
  • Manual non-rotary dental instrument handle
  • Dental implantation depth/angle gauge, reusable
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