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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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Teeth protector, metal - 04250381858646

size 1, small, with holes
Spiggle & Theis Medizintechnik GmbH
50-245-01
In Commercial Distribution

  • 04250381858646 ()
50-245-01

  • Mouthguard, reusable

Teeth protector, metal - 04250381858639

size 2, medium, with holes
Spiggle & Theis Medizintechnik GmbH
50-245-02
In Commercial Distribution

  • 04250381858639 ()
50-245-02

  • Mouthguard, reusable

Teeth protector, metal - 04250381858622

size 3, large, with holes
Spiggle & Theis Medizintechnik GmbH
50-245-03
In Commercial Distribution

  • 04250381858622 ()
50-245-03

  • Mouthguard, reusable

Orthex - 00841731112507

Orthex Pin Bolt with washer
VILEX IN TENNESSEE, INC.
C660
In Commercial Distribution

  • 00841731112507 ()
C660

  • External orthopaedic fixation system, single-use

OMNIBotics - 00841690195320

iBlock Sawing Guide with Cutout
Omni Life Science, Inc.
XK-06449
In Commercial Distribution

  • 00841690195320 ()
XK-06449

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Vitality Scanner - 00195062030086

GROUNDING LEAD WITH LIP CLIP
Kerr Corporation
973-0226
In Commercial Distribution

  • 00195062030086 ()


  • Dental pulp analysis system

RAPHAEL - 00841732108042

Hex Driver with Handle, 5.0
CTL Medical Corporation
015.7081
In Commercial Distribution

  • 00841732108042 ()


  • Internal spinal fixation procedure kit, reusable

PICASSO MIS Spinal System - 00841732108950

Hex Driver with Handle, 3.0
CTL Medical Corporation
016.7052
In Commercial Distribution

  • 00841732108950 ()


  • Surgical screwdriver, reusable

DEGAS Anterior Cervical Plate System - 00841732101074

Hex Driver with Handle, 2.35
CTL Medical Corporation
010.7061
In Commercial Distribution

  • 00841732101074 ()
010.7061

  • Spinal fixation plate, non-bioabsorbable

Orthex - 00841731114747

Orthex Strut Diagonal with QC
VILEX IN TENNESSEE, INC.
390-045-Q
In Commercial Distribution

  • 00841731114747 ()


  • External orthopaedic fixation system, single-use
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