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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Soothe-Guard Air® Adult Apron with Collar .35mm - Cool Grey
Dentsply International Inc.
862005001
In Commercial Distribution

  • D0038620050011 ()
862005001

  • Radiation shielding apron
Soothe-Guard Air® Adult Apron w/o Collar .35mm - Cool Grey
Dentsply International Inc.
862004902
In Commercial Distribution

  • D0038620049021 ()
862004902

  • Radiation shielding apron
Soothe-Guard Air® Adult Pano Vest .35mm - Light Blue
Dentsply International Inc.
861905900
In Commercial Distribution

  • D0038619059001 ()
861905900

  • Radiation shielding apron
Soothe-Guard Air® Child Dual Pano .35mm - Light Blue
Dentsply International Inc.
861905500
In Commercial Distribution

  • D0038619055001 ()
861905500

  • Radiation shielding apron
Soothe-Guard Air® Adult Dual Pano .35mm - Light Blue
Dentsply International Inc.
861905400
In Commercial Distribution

  • D0038619054001 ()
861905400

  • Radiation shielding apron
Soothe-Guard Air® Adult Pano Cape .35mm - Light Blue
Dentsply International Inc.
861905300
In Commercial Distribution

  • D0038619053001 ()
861905300

  • Radiation shielding apron
Soothe-Guard Air® Adult Apron with Collar .35mm - Light Blue
Dentsply International Inc.
861905001
In Commercial Distribution

  • D0038619050011 ()
861905001

  • Radiation shielding apron
Soothe-Guard Air® Adult Apron w/o Collar .35mm - Light Blue
Dentsply International Inc.
861904902
In Commercial Distribution

  • D0038619049021 ()
861904902

  • Radiation shielding apron
Soothe-Guard Air® Child Apron with Collar .35mm - Light Blue
Dentsply International Inc.
861904701
In Commercial Distribution

  • D0038619047011 ()
861904701

  • Radiation shielding apron
Soothe-Guard Air® Adult Pano Vest .35mm - Navy Blue
Dentsply International Inc.
861805900
In Commercial Distribution

  • D0038618059001 ()
861805900

  • Radiation shielding apron
Soothe-Guard Air® Child Dual Pano .35mm - Navy Blue
Dentsply International Inc.
861805500
In Commercial Distribution

  • D0038618055001 ()
861805500

  • Radiation shielding apron
Soothe-Guard Air® Adult Dual Pano .35mm - Navy Blue
Dentsply International Inc.
861805400
In Commercial Distribution

  • D0038618054001 ()
861805400

  • Radiation shielding apron
Soothe-Guard Air® Adult Pano Cape .35mm - Navy Blue
Dentsply International Inc.
861805300
In Commercial Distribution

  • D0038618053001 ()
861805300

  • Radiation shielding apron
Soothe-Guard Air® Adult Apron with Collar .35mm - Navy Blue
Dentsply International Inc.
861805001
In Commercial Distribution

  • D0038618050011 ()
861805001

  • Radiation shielding apron
Soothe-Guard Air® Adult Apron w/o Collar .35mm - Navy Blue
Dentsply International Inc.
861804902
In Commercial Distribution

  • D0038618049021 ()
861804902

  • Radiation shielding apron
Soothe-Guard Air® Child Apron with Collar .35mm - Navy Blue
Dentsply International Inc.
861804701
In Commercial Distribution

  • D0038618047011 ()
861804701

  • Radiation shielding apron
Soothe-Guard® Adult Apron w/o Collar .5mm - Navy Blue
Dentsply International Inc.
671804902
In Commercial Distribution

  • D0036718049021 ()
671804902

  • Radiation shielding apron
Soothe-Guard® Adult Pano Cape .35mm - Royal Blue
Dentsply International Inc.
662205300
In Commercial Distribution

  • D0036622053001 ()
662205300

  • Radiation shielding apron
Soothe-Guard® Adult Pano Cape .35mm - Sand
Dentsply International Inc.
662105300
In Commercial Distribution

  • D0036621053001 ()
662105300

  • Radiation shielding apron
Soothe-Guard® Adult Apron w/o Collar .35mm - Light Blue
Dentsply International Inc.
662104700
In Commercial Distribution

  • D0036621047001 ()
662104700

  • Radiation shielding apron
Soothe-Guard® Adult Apron w/o Collar .35mm - Cool Grey
Dentsply International Inc.
662004902
In Commercial Distribution

  • D0036620049021 ()
662004902

  • Radiation shielding apron
Soothe-Guard® Adult Apron w/o Collar .35mm - Light Blue
Dentsply International Inc.
661904902
In Commercial Distribution

  • D0036619049021 ()
661904902

  • Radiation shielding apron
Soothe-Guard® Child Apron with Collar .35mm - Light Blue
Dentsply International Inc.
661904700
In Commercial Distribution

  • D0036619047001 ()
661904700

  • Radiation shielding apron
Soothe-Guard® Adult Apron w/o Collar .35mm - Navy Blue
Dentsply International Inc.
661804902
In Commercial Distribution

  • D0036618049021 ()
661804902

  • Radiation shielding apron
INSTRUMENT
SEBIA
1244
In Commercial Distribution

  • 03607360012444 ()
1244

  • Electrophoresis analyser IVD
Suction Catheter, 12Fr, T-Piece, Tracheostomy, 72 Hour, with 22mm flex adapter, with Swivel, with HME Adapter, with Trach Wedge, with MDI Adapter
Twin Med, LLC
1005598
In Commercial Distribution

  • 30840330703544 ()
  • 10840330703540 ()
  • 50840330703548 ()
  • 70840330703542 ()

  • Catheter Gauge: 12 French
  • Catheter Inner Diameter: 4 Millimeter
  • Length: 30.5 Centimeter
1005598

  • Airway suction catheter
SeroVac® II Drain, With Needle, With Blunt Needle, With Connection Tubing, With Vacuum Tubes and Connector
AXIOM MEDICAL, INCORPORATED
225
In Commercial Distribution

  • M6652253 ()
  • M6652251 ()
  • M6652250 ()

  • Length: 5.2 Inch
  • 14 gauge
  • Total Volume: 10 Milliliter


  • Closed-wound drain, non-bioabsorbable
SeroVac® II Drain, With Needle, With Blunt Needle, With Connection Tubing, With Vacuum Tubes and Connector
AXIOM MEDICAL, INCORPORATED
223
In Commercial Distribution

  • M6652233 ()
  • M6652231 ()
  • M6652230 ()

  • Total Volume: 10 Milliliter
  • 14 gauge
  • Length: 3.5 Inch


  • Closed-wound drain, non-bioabsorbable
Console with Accessories For use with Kangaroo Feeding Tubes with IRIS Technology
Cardinal Health, Inc.
386100
In Commercial Distribution

  • 10884521164987 ()

  • No;
386100

  • Electrical-only medical device connection cable, reusable
SeroVac® II Drain, With Needle, With Blunt Needle, With Connection Tubing
AXIOM MEDICAL, INCORPORATED
224
In Commercial Distribution

  • M6652243 ()
  • M6652241 ()
  • M6652240 ()

  • 14 gauge
  • Length: 5.2 Inch


  • Closed-wound drain, non-bioabsorbable
SeroVac® II Drain, With Needle, With Blunt Needle, With Connection Tubing
AXIOM MEDICAL, INCORPORATED
222
In Commercial Distribution

  • M6652223 ()
  • M6652221 ()
  • M6652220 ()

  • Length: 5.2 Inch
  • 14 gauge


  • Closed-wound drain, non-bioabsorbable
DreamStation BiPAP autoSV with Humidifier, with Heated Tube, with Cell Modem, Australia
Respironics, Inc.
DreamStation BiPAP autoSV w/Humid w/H tube w/Cell, AU
In Commercial Distribution

  • 00606959045828 ()
AUX900T15C

  • Portable electric ventilator
DreamStation BiPAP AVAPS30 AE with Humidifier, with Heated Tube, with WiFi, Australia
Respironics, Inc.
DreamStation BiPAP AVAPS30 AE w/Humid w/H Tube w/WiFi, AU
In Commercial Distribution

  • 00606959045750 ()
AUX1131T15W

  • Portable electric ventilator
DreamStation BiPAP AVAPS30 with Humidifier, with Heated Tube, with Cell Modem, Canada
Respironics, Inc.
DreamStation BiPAP AVAPS30 w/Humid w/H Tube w/Cell, CA
In Commercial Distribution

  • 00606959045729 ()
CAX1130T12C

  • Portable electric ventilator
DreamStation BiPAP AVAPS30 with Humidifier, with Heated Tubing, with Cell Modem, USA
Respironics, Inc.
DreamStation AVAPS30 w/Humid w/H Tube w/Cell, US
In Commercial Distribution

  • 00606959045668 ()
DSX1130T11C

  • Portable electric ventilator
Elvarex 2/Glove/With Finger, with Thumb
BSN-Jobst GmbH
77558-00017-00
In Commercial Distribution

  • 04019702287943 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 1/Glove/With Finger, with Thumb
BSN-Jobst GmbH
77325-00003-00
In Commercial Distribution

  • 04019702316551 ()

  • Pressure: 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
S-568 BARRIER WITH CUTOUT WITH S-511 LAMP
AADCO MEDICAL, INC.
OS-568HL
In Commercial Distribution

  • 00840348501650 ()
OS-568HL

  • Radiation shielding panel, fixed
Lap Chole Case, with latches, with insert
Avalign Technologies, Inc.
95-2000100017
In Commercial Distribution

  • 00190776140113 ()


  • Spinal rongeur
PDO THREADS WITH BIOABSORBABLE MATERIAL WITH NEEDLE
MEDYGLOBAL MEDICAL DEVICES SL.
20X1
Not in Commercial Distribution

  • B772DWB2102 ()
  • SCREWCOG21GX90 ()
21GX90

  • Composite-polymer suture
PDO THREADS WITH BIOABSORBALE MATERIAL WITH NEEDLE
MEDYGLOBAL MEDICAL DEVICES SL.
20X1
Not in Commercial Distribution

  • B772DWB1903 ()
  • SUPERTORNADO19GX100 ()
19GX100

  • Composite-polymer suture
Brief with Sleeves, with Flap or Snaps
Gottfried Medical, Inc.
416
In Commercial Distribution

  • G420416 ()
416

  • Compression/pressure shirt/pants
Bierer Ovum Forceps with teeth, with ratchet
Avalign Technologies, Inc.
9-115719
In Commercial Distribution

  • 00190776117962 ()


  • Open-surgery biopsy forceps, reusable
Bierer Ovum Forceps with teeth, with ratchet
Avalign Technologies, Inc.
9-115716
In Commercial Distribution

  • 00190776117955 ()


  • Open-surgery biopsy forceps, reusable
Analyzer with BlenderBuddy International 0-15 with DISS
MAXTEC, LLC
R219P62-001
Not in Commercial Distribution

  • 00817770021018 ()


  • Respiratory oxygen monitor, line-powered
UGD ear probe with with left-ear identification
OTODYNAMICS LIMITED
PR-ABRLD
In Commercial Distribution

  • 05060396171260 ()


  • Evoked-potential audiometer
Wheelchair Scale with Fold Seat with BT
Pelstar, LLC
2500CKL-BT
In Commercial Distribution

  • 00851628008356 ()


  • Wheelchair-accessible platform scale
with Rectal Split Balloon with Introducer, 6F
Laborie Medical Technologies Canada ULC
9021T1141
In Commercial Distribution

  • 10627825007570 ()
  • 00627825007566 ()


  • Urodynamic manometric catheter, non-electronic
with Rectal Split Balloon with Introducer, 10F
Laborie Medical Technologies Canada ULC
9021T1081
In Commercial Distribution

  • 10627825007488 ()
  • 00627825007474 ()


  • Urodynamic manometric catheter, non-electronic
with Rectal Split Balloon with Introducer, 6F
Laborie Medical Technologies Canada ULC
9021T1051
In Commercial Distribution

  • 10627825007396 ()
  • 00627825007382 ()


  • Urodynamic manometric catheter, non-electronic
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