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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DB BKT MASTER HGW UL BIC 018 T-7 A=0 R=0 OFFSET PAD GP
AMERICAN ORTHODONTICS CORPORATION
390-8807AUUL
In Commercial Distribution

  • 00190746173523 ()
390-8807AUUL

  • Orthodontic bracket, metal
DB BKT MINI MS UR BIC 022 T-7 A=0 R=0 GP 197 PAD
AMERICAN ORTHODONTICS CORPORATION
970-1027AUUR
In Commercial Distribution

  • 00190746172977 ()
970-1027AUUR

  • Orthodontic bracket, metal
DB BKT MINI MS UL BIC 022 T-7 A=0 R=0 GP 197 PAD
AMERICAN ORTHODONTICS CORPORATION
970-1027AUUL
In Commercial Distribution

  • 00190746172960 ()
970-1027AUUL

  • Orthodontic bracket, metal
DB BKT MINI MS UR BIC 018 T-7 A=0 R=0 GP OFFSET PAD
AMERICAN ORTHODONTICS CORPORATION
390-8007AUUR
In Commercial Distribution

  • 00190746172113 ()
390-8007AUUR

  • Orthodontic bracket, metal
DB BKT MINI MS UL BIC 018 T-7 A=0 R=0 GP OFFSET PAD
AMERICAN ORTHODONTICS CORPORATION
390-8007AUUL
In Commercial Distribution

  • 00190746172106 ()
390-8007AUUL

  • Orthodontic bracket, metal
DB TUBE SLIM LL 1ST MOL 022 NON-CONV T-25 R=0 3.8MM W/HK GP
AMERICAN ORTHODONTICS CORPORATION
956-4023CAU
Not in Commercial Distribution

  • 00190746163265 ()
956-4023CAU

  • Orthodontic tube
DB TUBE SLIM LR 1ST MOL 022 NON-CONV T-25 R=0 3.8MM W/HK GP
AMERICAN ORTHODONTICS CORPORATION
955-4022CAU
Not in Commercial Distribution

  • 00190746163210 ()
955-4022CAU

  • Orthodontic tube
Airwave Oscillometry System to measure respiratory system impedance using the Forced Oscillation Technique (FOT). Version compatible with ClearFlo PFT filter. Includes power supply, ethernet cable, and user manual.
Thorasys Thoracic Medical Systems Inc
101336
In Commercial Distribution

  • 07540261013362 ()


  • Pulmonary function analysis system, adult
Legend Pro H7X7 DISPOSABLE TIP ASSY 5 PACKED
POLLOGEN LTD
H7X7
In Commercial Distribution

  • 07290016586206 ()
  • 17290016586203 ()
30010140LP

  • Radio-frequency skin contouring system applicator tip
Cut gutta percha quickly, cleanly, and safely within the pulp chamber with the cordless GP Cut Gutta Percha Cutter. Hold the power button for one second and the tip will reach up to 1,000°C. Release the button, and the tip cools down in less than one second. Bendable, flexible tips come in three sizes: large (2.0mm wide), medium (1.2mm wide), and small (0.5mm wide). The GP Cut system comes complete with one unit, one base, protective cap, and three tips (one of each size). 7.875" long x .75" wide. Powered by two AA batteries
PRACTICON, INC.
1362
In Commercial Distribution

  • 00723896005361 ()
71-36210

  • Endodontic plugger
No Description
Heine Optotechnik GmbH & Co. KG
ADULT LARGE
In Commercial Distribution

  • 04053755186013 ()
M-000.09.706

  • Blood pressure cuff, reusable
GC Fuji IX GP® Starter Package, A2 (1 x 15g powder, 1 x 6.4mL liquid, 1 x GC CAVITY CONDITIONER, 1 x GC Fuji COAT LC)
Gc America Inc.
439901
In Commercial Distribution

  • 10386040009881 ()
439901

  • Glass ionomer dental cement
GC Fuji IX GP® Capsule (48) Assorted Starter (10 each of A2, A3, A3.5, 9 each of B2 & B3, Capsule Applier, Cavity Conditioner, and Fuji COAT LC)
Gc America Inc.
425090
In Commercial Distribution

  • 00386040009099 ()
  • 10386040009096 ()
425090

  • Glass ionomer dental cement
GC Fuji IX GP® Capsule (48) Assorted (10 each of A2, A3, A3.5, 9 each of B2 & B3)
Gc America Inc.
425080
In Commercial Distribution

  • 00386040009037 ()
  • 10386040009034 ()
425080

  • Glass ionomer dental cement
GC Fuji IX GP® FAST Capsule (48) Assorted Starter (10 each of A2, A3, A3.5, 9 each of B2 & B3, Capsule Applier, Cavity Conditioner, and Fuji COAT LC)
Gc America Inc.
425070
In Commercial Distribution

  • 00386040009020 ()
  • 10386040009027 ()
425070

  • Glass ionomer dental cement
GC Fuji IX GP® FAST Capsule (48) Assorted (10 each of A2, A3, A3.5, 9 each of B2 & B3)
Gc America Inc.
425060
In Commercial Distribution

  • 00386040008955 ()
  • 10386040008952 ()
425060

  • Glass ionomer dental cement
GC Fuji IX GP® EXTRA Capsule (48) Assorted Starter (10 each of A2, A3,A3.5, 9 each of B1 & B3, Capsule Applier, Cavity Conditioner, and Fuji COAT LC)
Gc America Inc.
425050
In Commercial Distribution

  • 00386040008948 ()
  • 10386040008945 ()
425050

  • Glass ionomer dental cement
GC Fuji IX GP® EXTRA Assorted Pkg Capsule (48) (10 each of A2 A3,A3.5, 9 each of B1 & B3)
Gc America Inc.
425040
In Commercial Distribution

  • 00386040008856 ()
  • 10386040008853 ()
425040

  • Glass ionomer dental cement
HYDROPHILIC COATED MINI-PIGTAIL LOCKING CATHETER WITH DEPTH MARKS, 10F
URESIL, LLC
MPL2-1030H
In Commercial Distribution

  • 10817640020339 ()
  • 00817640020332 ()
  • 20817640020336 ()
  • H862MPL21030H0 ()

  • Catheter Gauge: 10 French
  • Length: 25 Centimeter
MPL2-1030H

  • Suction system catheter, general-purpose
HYDROPHILIC COATED MINI-PIGTAIL LOCKING CATHETER WITH DEPTH MARKS, 8F
URESIL, LLC
MPL2-0830H
In Commercial Distribution

  • 10817640020322 ()
  • 00817640020325 ()
  • 20817640020329 ()
  • H862MPL20830H0 ()

  • Catheter Gauge: 8 French
  • Length: 25 Centimeter
MPL2-0830H

  • Suction system catheter, general-purpose
HYDROPHILIC COATED MINI-PIGTAIL LOCKING CATHETER WITH DEPTH MARKS, 6F
URESIL, LLC
MPL2-0625H
In Commercial Distribution

  • 10817640020315 ()
  • 00817640020318 ()
  • 20817640020312 ()
  • H862MPL20625H0 ()

  • Catheter Gauge: 6 French
  • Length: 20 Centimeter
MPL2-0625H

  • Suction system catheter, general-purpose
HYDROPHILIC COATED SHORT MINI-PIGTAIL LOCKING CATHETER WITH DEPTH MARKS, 10F
URESIL, LLC
KDL2-1017H
In Commercial Distribution

  • 10817640020278 ()
  • 00817640020271 ()
  • 20817640020275 ()
  • H862KDL21017H0 ()

  • Catheter Gauge: 10 French
  • Length: 12 Centimeter
KDL2-1017H

  • Suction system catheter, general-purpose
HYDROPHILIC COATED SHORT MINI-PIGTAIL LOCKING CATHETER WITH DEPTH MARKS, 8F
URESIL, LLC
KDL2-0817H
In Commercial Distribution

  • 10817640020261 ()
  • 00817640020264 ()
  • 20817640020268 ()
  • H862KDL20817H0 ()

  • Catheter Gauge: 8 French
  • Length: 12 Centimeter
KDL2-0817H

  • Suction system catheter, general-purpose
HYDROPHILIC COATED SHORT MINI-PIGTAIL LOCKING CATHETER WITH DEPTH MARKS, 6F
URESIL, LLC
KDL2-0617H
In Commercial Distribution

  • 10817640020254 ()
  • 00817640020257 ()
  • 20817640020251 ()
  • H862KDL20617H0 ()

  • Catheter Gauge: 6 French
  • Length: 12 Centimeter
KDL2-0617H

  • Suction system catheter, general-purpose
HYDROPHILIC COATED MINI-PIGTAIL LOCKING CATHETER WITH DEPTH MARKS, 12F
URESIL, LLC
MPL2-1230H
In Commercial Distribution

  • 10817640021688 ()
  • 00817640021681 ()
  • 20817640021685 ()
  • H862MPL21230H0 ()

  • Catheter Gauge: 12 French
  • Length: 22 Centimeter
MPL2-1230H

  • Suction system catheter, general-purpose
HYDROPHILIC COATED MINI-PIGTAIL LOCKING CATHETER WITH DEPTH MARKS, 12F
URESIL, LLC
MPL2T-1230H
In Commercial Distribution

  • 10817640021671 ()
  • 00817640021674 ()
  • 20817640021678 ()
  • H862MPL2T1230H0 ()

  • Catheter Gauge: 12 French
  • Length: 22 Centimeter
MPL2T-1230H

  • Suction system catheter, general-purpose
HYDROPHILIC COATED MINI-PIGTAIL LOCKING CATHETER WITH DEPTH MARKS, 12F
URESIL, LLC
MPL2-1430H
In Commercial Distribution

  • 10817640021664 ()
  • 00817640021667 ()
  • 20817640021661 ()
  • H862MPL21430H0 ()

  • Catheter Gauge: 14 French
  • Length: 24 Centimeter
MPL2-1430H

  • Suction system catheter, general-purpose
HYDROPHILIC COATED MINI-PIGTAIL LOCKING CATHETER WITH DEPTH MARKS, 12F
URESIL, LLC
MPL2T-1430H
In Commercial Distribution

  • 10817640021657 ()
  • 00817640021650 ()
  • 20817640021654 ()
  • H862MPLT21430H0 ()

  • Catheter Gauge: 14 French
  • Length: 24 Centimeter
MPL2T-1430H

  • Suction system catheter, general-purpose
HYDROPHILIC COATED MINI-PIGTAIL LOCKING CATHETER, 10F
URESIL, LLC
MPL2-1030HB
In Commercial Distribution

  • 10817640021367 ()
  • 00817640021360 ()
  • 20817640021364 ()
  • H862MPL21030HB0 ()

  • Catheter Gauge: 10 French
  • Length: 25 Centimeter
MPL2-1030HB

  • Suction system catheter, general-purpose
HYDROPHILIC COATED MINI-PIGTAIL LOCKING CATHETER, 8F
URESIL, LLC
MPL2-0830HB
In Commercial Distribution

  • 10817640021350 ()
  • 00817640021353 ()
  • 20817640021357 ()
  • H862MPL20830HB0 ()

  • Catheter Gauge: 8 French
  • Length: 25 Centimeter
MPL2-0830HB

  • Suction system catheter, general-purpose
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