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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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Brush&Bond® Kit with Mini/Endo B&B Activator Brushes
PARKELL, INC.
S288
Not in Commercial Distribution

  • M595S2880 ()
S288

  • Dentine bonding agent/set
20:1, EP Type E-CUBE(C/B)+CUBE-EP+ACL(B)-42EP
Saeshin Precision Co., Ltd.
E-CUBE #1
In Commercial Distribution

  • 08809260470910 ()


  • Dental power tool system, line-powered
20:1, EM Type E-CUBE(C/B)+CUBE-EM+ACL(B)-42EM
Saeshin Precision Co., Ltd.
E-CUBE #2
In Commercial Distribution

  • 08809260470903 ()


  • Dental power tool system, line-powered
ER7C series B Microphone ER7C series B Pre-Amp ER7-14 Probe Tubes
ETYMOTIC RESEARCH, INC.
ER7C Probe Microphone Series B
In Commercial Distribution

  • 00846430004955 ()


  • Audiometric/hearing aid tester
Temporary Cap for Standard Abutment b/1.5/6.0 & b/3.0/6.0
Dentsply Implants Manufacturing GmbH
31045310
Not in Commercial Distribution

  • EFRI310453102 ()
31045310

  • Dental implant suprastructure, temporary, preformed, single-use
Temporary Cap for Standard Abutment b/1.5/4.0 & b/3.0/4.0
Dentsply Implants Manufacturing GmbH
31045300
Not in Commercial Distribution

  • EFRI310453002 ()
31045300

  • Dental implant suprastructure, temporary, preformed, single-use
Gold Coping, Degunorm b/1.5/6.0 & b/3.0/6.0 with screw
Dentsply Implants Manufacturing GmbH
31056190
Not in Commercial Distribution

  • EFRI310561902 ()
31056190

  • Dental implant suprastructure, permanent, preformed
Gold Coping, Degunorm b/1.5/4.0 & b/3.0/4.0 with screw
Dentsply Implants Manufacturing GmbH
31056180
Not in Commercial Distribution

  • EFRI310561802 ()
31056180

  • Dental implant suprastructure, permanent, preformed
Gold Coping, Permador b/1.5/6.0 & b/3.0/6.0 with screw
Dentsply Implants Manufacturing GmbH
31056130
Not in Commercial Distribution

  • EFRI310561302 ()
31056130

  • Dental implant suprastructure, permanent, preformed
Gold Coping, Permador b/1.5/4.0 & b/3.0/4.0 with screw
Dentsply Implants Manufacturing GmbH
31056120
Not in Commercial Distribution

  • EFRI310561202 ()
31056120

  • Dental implant suprastructure, permanent, preformed
4 1/2" Stevens Tenotomy Scissors, Curved, B/B, Super Cut
Surgical Direct, Inc.
SD90347711SC
In Commercial Distribution

  • B382SD90347711SC0 ()
SD90347711SC

  • General-purpose surgical scissors, single-use
Brush&Bond® Kit with Mini/Endo B&B Activator Brushes
PARKELL, INC.
S288
In Commercial Distribution

  • 00810000529155 ()
S288

  • Dentine bonding agent/set
Gold Coping, Degunorm b/1.5/6.0 & b/3.0/6.0 with screw
Dentsply Implants Manufacturing GmbH
31056190
In Commercial Distribution

31056190

  • Dental implant suprastructure, permanent, preformed
Gold Coping, Degunorm b/1.5/4.0 & b/3.0/4.0 with screw
Dentsply Implants Manufacturing GmbH
31056180
In Commercial Distribution

31056180

  • Dental implant suprastructure, permanent, preformed
Gold Coping, Permador b/1.5/6.0 & b/3.0/6.0 with screw
Dentsply Implants Manufacturing GmbH
31056130
In Commercial Distribution

  • 07392532222344 ()
31056130

  • Dental implant suprastructure, permanent, preformed
Gold Coping, Permador b/1.5/4.0 & b/3.0/4.0 with screw
Dentsply Implants Manufacturing GmbH
31056120
In Commercial Distribution

  • 07392532222337 ()
31056120

  • Dental implant suprastructure, permanent, preformed
Temporary Cap for Standard Abutment b/1.5/6.0 & b/3.0/6.0
Dentsply Implants Manufacturing GmbH
31045310
In Commercial Distribution

31045310

  • Dental implant suprastructure, permanent, preformed
Temporary Cap for Standard Abutment b/1.5/4.0 & b/3.0/4.0
Dentsply Implants Manufacturing GmbH
31045300
In Commercial Distribution

31045300

  • Dental implant suprastructure, permanent, preformed
Laboratory Analog one piece 15° b/1.5/6.0 & b/3.0/6.0
Dentsply Implants Manufacturing GmbH
31045172
In Commercial Distribution

  • 07392532221217 ()
31045172

  • Dental implant suprastructure, temporary, preformed, single-use
Laboratory Analog one piece b/1.5/6.0 & b/3.0/6.0 straight
Dentsply Implants Manufacturing GmbH
31045170
In Commercial Distribution

  • 07392532221200 ()
31045170

  • Dental implant suprastructure, temporary, preformed, single-use
Laboratory Analog one piece 15° b/1.5/4.0 & b/3.0/4.0
Dentsply Implants Manufacturing GmbH
31045162
In Commercial Distribution

  • 07392532221194 ()
31045162

  • Dental implant suprastructure, temporary, preformed, single-use
Laboratory Analog one piece b/1.5/4.0 & b/3.0/4.0 straight
Dentsply Implants Manufacturing GmbH
31045160
In Commercial Distribution

  • 07392532221187 ()
31045160

  • Dental implant suprastructure, temporary, preformed, single-use
Biowave Noninvasive Electrode - B-Set
BIOWAVE CORPORATION
MK78560 - BWEN01-B
In Commercial Distribution

  • 20859911006083 ()
  • 10859911006086 ()
  • 00859911006089 ()


  • Transcutaneous electrical stimulation electrode, single-use
Biowave Percutaneous Electrode Set - B
BIOWAVE CORPORATION
MK78505 - BWEP01-B
In Commercial Distribution

  • 20859911006007 ()
  • 10859911006000 ()
  • 00859911006003 ()


  • Analgesic PENS system probe, single-use
No Description
MASIMO CORPORATION
1775
In Commercial Distribution

  • 10843997000489 ()
  • 00843997000482 ()


  • Pulse oximeter probe, single-use
No Description
MASIMO CORPORATION
1777
In Commercial Distribution

  • 10843997000472 ()
  • 00843997000475 ()


  • Pulse oximeter probe, single-use
No Description
MASIMO CORPORATION
1774
In Commercial Distribution

  • 10843997000465 ()
  • 00843997000468 ()


  • Pulse oximeter probe, single-use
No Description
MASIMO CORPORATION
2335
In Commercial Distribution

  • 00843997001434 ()


  • Electrical-only medical device connection cable, reusable
No Description
MASIMO CORPORATION
1949
In Commercial Distribution

  • 00843997001427 ()


  • Electrical-only medical device connection cable, reusable
No Description
MASIMO CORPORATION
1900
In Commercial Distribution

  • 00843997001410 ()


  • Electrical-only medical device connection cable, reusable
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