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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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KMI IMI GROUP - 00851314007113

Handles & Adaptors
Innovative Med
19-0092
In Commercial Distribution

  • 00851314007113 ()


  • Liposuction system cannula, reusable
  • Collection syringe adaptor, reusable

Spline® - 00889024012950

No Description
ZIMMER DENTAL INC.
1946
In Commercial Distribution

  • 00889024012950 ()

  • Ø5.0mm, Ø5.0mm x 5mm


  • Dental implant suprastructure, temporary, preformed, single-use

N/A - 00840329814359

INJECTION GUN FOR MONOJECT TOOMEY 60CC SYRINGE
BLACK & BLACK SURGICAL, INC.
B89IGS-60CC
In Commercial Distribution

  • 00840329814359 ()
B89IGS-60CC

  • Syringe autofill kit

N/A - 00840329814342

INJECTION GUN SET, FOR 3CC, 5CC, 10CC BD SYRINGE
BLACK & BLACK SURGICAL, INC.
B89IGS-3510CC
In Commercial Distribution

  • 00840329814342 ()
B89IGS-3510CC

  • Syringe autofill kit

3Shape Scan Bodies - 05902729751452

Camlog - Screwdriver
3shape Trios A/S
CC
In Commercial Distribution

  • 05902729751452 ()


  • Dental milling system, CAD/CAM, laboratory

iOptima APP - J00714000630631

iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400063
In Commercial Distribution

  • J00714000630631 ()
1400063

  • Dental treatment application software

iChiropro APP - J00714000510511

iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400051
In Commercial Distribution

  • J00714000510511 ()
1400051

  • Surgical power tool system control unit, line-powered

iChiropro Surgery APP - J00714000520521

iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400052
In Commercial Distribution

  • J00714000520521 ()
1400052

  • Surgical power tool system control unit, line-powered
  • Dental treatment application software

Truliant CC - 10885862630186

TRULIANT 10 MM LONG IM PILOT DRILL WITH TROCAR TIP
Exactech, Inc.
02-019-30-0100
In Commercial Distribution

  • 10885862630186 ()
02-019-30-0100

  • Bone-resection orthopaedic reamer, reusable

Truliant CC - 10885862629852

TRULIANT STEM EXT TRIAL15MM X 120MM
Exactech, Inc.
02-013-60-1512
In Commercial Distribution

  • 10885862629852 ()
02-013-60-1512

  • Knee femur prosthesis trial, reusable
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