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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Fall Guardian Economy Monitor with bed pad case
Smart Caregiver Corporation
FG2B45W-SYS/CS
In Commercial Distribution

  • 00812293015339 ()


  • Bed/chair occupant movement pressure/vibration sensor
Fall Guardian Economy Monitor with bed pad case
Smart Caregiver Corporation
FG2B45R-SYS/CS
In Commercial Distribution

  • 00812293015322 ()


  • Bed/chair occupant movement pressure/vibration sensor
Fall Guardian Economy Monitor with bed pad case
Smart Caregiver Corporation
FG2B90W-SYS/CS
In Commercial Distribution

  • 00812293015308 ()


  • Bed/chair occupant movement pressure/vibration sensor
Fall Guardian Economy Monitor with bed pad case
Smart Caregiver Corporation
FG2B90R-SYS/CS
In Commercial Distribution

  • 00812293015292 ()


  • Bed/chair occupant movement pressure/vibration sensor
Fall Guardian Economy Monitor with chair pad case
Smart Caregiver Corporation
FG2C1-SYS/CS
In Commercial Distribution

  • 00812293015285 ()


  • Bed/chair occupant movement pressure/vibration sensor
Fall Guardian Economy Monitor with bed pad case
Smart Caregiver Corporation
FG2BW1-SYS/CS
In Commercial Distribution

  • 00812293015278 ()


  • Bed/chair occupant movement pressure/vibration sensor
Fall Guardian Economy Monitor with bed pad case
Smart Caregiver Corporation
FG2BR1-SYS/CS
In Commercial Distribution

  • 00812293015261 ()


  • Bed/chair occupant movement pressure/vibration sensor
Disposable Medical Electrodes 300 electrodes per EACH (case)
GRAPHIC CONTROLS ACQUISITION CORP
019-427000
Not in Commercial Distribution

  • 00813150020954 ()
019-427000

  • Analytical non-scalp cutaneous electrode
Vital™ MIS Instrument Case 1 Top Tray
ZIMMER BIOMET INC
800M1200-02
In Commercial Distribution

  • 00887868360459 ()


  • Instrument tray, reusable
Phonak Charger Case RIC incl US power supply
Sonova AG
075-0111-11
In Commercial Distribution

  • 07613389087802 ()
075-0111-11

  • Noninvasive device battery charger
Phonak Charger Case BTE incl US power supply
Sonova AG
075-0113-11
In Commercial Distribution

  • 07613389087666 ()
075-0113-11

  • Noninvasive device battery charger
5 InCup w/4M+ BZO opi3 25/case
AMERICAN BIO MEDICA CORPORATION
10-5MZC-030
In Commercial Distribution

  • 10694644400271 ()
  • 10694644450276 ()
10-5MZC-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
Medfix Vision Universal 3 Level Small Case Lid
NEXUS SPINE, L.L.C.
821083.42
Not in Commercial Distribution

  • B678821083420 ()


  • Spinal fixation plate, non-bioabsorbable
Medfix Vision Universal 1 Level Large Case Lid
NEXUS SPINE, L.L.C.
821082.06
Not in Commercial Distribution

  • B678821082060 ()


  • Spinal fixation plate, non-bioabsorbable
LIDMedfix Vision Universal 2 Level Small Case Lid
NEXUS SPINE, L.L.C.
821081.23
Not in Commercial Distribution

  • B678821081230 ()


  • Spinal fixation plate, non-bioabsorbable
PEDIATRIC URINE COLLECTORS, STERILE, 100/Box, 500/Case
PRECISION DYNAMICS CORPORATION
05002
In Commercial Distribution

  • 10687225793596 ()
  • 10687225793756 ()
  • 10687225794708 ()
05002-00-SSB (Y5178898)

  • Adhesive paediatric urine collection bag, open-ended
PEDIATRIC URINE COLLECTORS, CLEAN, 100/Box, 500/Case
PRECISION DYNAMICS CORPORATION
05001
In Commercial Distribution

  • 10687225793749 ()
  • 10687225794692 ()
  • 10687225793589 ()
05001-00-SCB (Y5178897)

  • Adhesive paediatric urine collection bag, open-ended
3O+amp/bar/bzo/bup/op3 25/case
AMERICAN BIO MEDICA CORPORATION
10-7BX2-030
In Commercial Distribution

  • 10694644200185 ()
  • 10694644250180 ()
10-7BX2-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
EXPEDIUM SPINE SYSTEM THREE LEVEL CASE AND LID
Medos International Sàrl
279784300
In Commercial Distribution

  • 10705034202648 ()
279784300

  • Instrument tray, reusable
EXPEDIUM SPINE SYSTEM TWO LEVEL CASE AND LID
Medos International Sàrl
279784200
In Commercial Distribution

  • 10705034202495 ()
279784200

  • Instrument tray, reusable
EXPEDIUM SPINE SYSTEM DUAL INNER CASE LICENSE PLATE
DEPUY SPINE, LLC
279782205
In Commercial Distribution

  • 10705034201368 ()
279782205

  • Instrument tray, reusable
MONARCH SPINE SYSTEM LOW BACK CORE INSTRUMENT CASE
DEPUY SPINE, LLC
277095000
Not in Commercial Distribution

  • 10705034197470 ()
277095000

  • Instrument tray, reusable
MOSS MIAMI SPINE SYSTEM LOW BACK IMPLANT CASE
DEPUY SPINE, LLC
275502001
Not in Commercial Distribution

  • 10705034194929 ()
275502001

  • Instrument tray, reusable
Portable sealer for blood bag tubes - Case Kit
DELCON SRL
HWG2.00V
In Commercial Distribution

  • 08033928530139 ()


  • Blood donor bag tube divider/sealer
MOSS MIAMI SPINE SYSTEM LOW BACK IMPLANT CASE
DEPUY SPINE, LLC
274500100
In Commercial Distribution

  • 10705034192055 ()
274500100

  • Instrument tray, reusable
PFT Kit B, 35mm Pulmonary Function Kit - Case
A-M SYSTEMS, LLC
PFT Kit B - 180052
In Commercial Distribution

  • 00817081021233 ()
  • 00817081021226 ()
  • 00817081021578 ()
180052

  • Pulmonary function testing kit
VBMax36 Pulmonary Function Testing Filter - Case PFT Diagnostics
A-M SYSTEMS, LLC
VBMax36 - 156616
In Commercial Distribution

  • 00817081021134 ()
  • 00817081021127 ()
156616

  • Pulmonary function testing filter/mouthpiece
VBMax34E, Disposable Pulmonary Function Testing Filter GraceMed Case
A-M SYSTEMS, LLC
VBMax34E - 146407
In Commercial Distribution

  • 00817081020991 ()
  • 00817081020984 ()
146407

  • Pulmonary function testing filter/mouthpiece
DELTA Xtend REV CASE ADDITIONAL TAP TRAY 2
DEPUY (IRELAND)
240799941
In Commercial Distribution

  • 10603295286011 ()
240799941

  • Instrument tray, reusable
REVELATION microMAX RT BROACH AND NK TRIAL CASE
Encore Medical, L.P.
803-99-055
In Commercial Distribution

  • 00888912105798 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
CASE, EMPOWR PS KNEETM FEM PREP- TRIAL, LARGE
Encore Medical, L.P.
800-99-108
In Commercial Distribution

  • 00888912545341 ()


  • Instrument tray, reusable
CASE, EMPOWR PS KNEETM FEM PREP- TRIAL, SMALL
Encore Medical, L.P.
800-99-107
In Commercial Distribution

  • 00888912545334 ()


  • Instrument tray, reusable
Smart Correction Two Third and Foot Ring Case
Wishbone Medical, Inc.
SC-RINGCASE2NS
Not in Commercial Distribution

  • B562SCRINGCASE2NSE0 ()


  • Instrument tray, reusable
Smart Correction Two Third and Foot Ring Case
Wishbone Medical, Inc.
SC-RINGCASE2
Not in Commercial Distribution

  • B562SCRINGCASE20 ()
SC-RINGCASE2

  • Instrument tray, reusable
Patient Bibs 3PLY POLY 13X18 YELLOW 500/Case
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
B3-YE
In Commercial Distribution

  • 00817169022978 ()
B3-YE

  • Dental bib
Patient Bibs 3PLY POLY 13X18 PEACH 500/Case
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
B3-PE
In Commercial Distribution

  • 00817169022954 ()
B3-PE

  • Dental bib
Patient Bibs 3PLY POLY 13X18 BEIGE 500/Case
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
B3-BE
In Commercial Distribution

  • 00817169022923 ()
B3-BE

  • Dental bib
Patient Bibs 3PLY POLY 13X18 MAUVE 500/Case
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
B3-DR
In Commercial Distribution

  • 00817169022916 ()
B3-DR

  • Dental bib
Patient Bibs 3PLY POLY 13X18 LAVENDER 500/Case
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
B3-WH
In Commercial Distribution

  • 00817169022909 ()
B3-WH

  • Dental bib
Patient Bibs 3PLY+POLY 13X18 WHITE 500/Case
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
B3-WH
In Commercial Distribution

  • 00817169022893 ()
B3-WH

  • Dental bib
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