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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Innospire Elegance, Custom New Hope Medical Supplies, 6-pack
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00
In Commercial Distribution

  • 00383730003283 ()
1105293

  • Benchtop nebulizer, non-heated
KIT,G 3 ANT CERV LAMI,NEW YOR
Cardinal Health 200, LLC
PNV2CL34J
In Commercial Distribution

  • 50887488521709 ()
  • 10887488521701 ()
PNV2CL34J

  • Neurosurgical procedure kit, non-medicated, single-use
NEW ORLEANS NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED TIP
SONTEC INSTRUMENTS, INC.
2300-499
In Commercial Distribution

  • 00192896062818 ()

  • Length: 6 Inch
2300-499

  • Suturing needle holder, reusable
PlasmaJet Ultra Plus Console System In-Service (New Zealand)
PLASMA SURGICAL, INC
PS10-3130IS-NZ
In Commercial Distribution

  • M397PS103130ISNZ0 ()
PS10-3130IS-NZ

  • Plasma surgical system
Symmetry® Needle Holder; New Orleans; 7 in
SYMMETRY SURGICAL INC.
32-150
In Commercial Distribution

  • 00887482069349 ()

  • Length: 7 Inch
32-150

  • Suturing needle holder, reusable
36PW - New York City School Bus - Poly White
Certified Safety Manufacturing, Inc.
S914-001
In Commercial Distribution

  • 00766588140018 ()
S914-001

  • First aid kit, medicated
Mindray Compatible New Style ECG Trunk Cable, 3.0M
APK Technology Co.,Ltd.
MDR-009-005266-00
In Commercial Distribution

  • 06946725538159 ()


  • Electrocardiographic lead set, reusable
PlasmaJet V3 Plus Console System In-Service (New Zealand)
PLASMA SURGICAL, INC
PS10-2130IS-NZ
In Commercial Distribution

  • M397PS102130ISNZ0 ()
PS10-2130IS-NZ

  • Plasma surgical system
CUSTOM PACK 1G75R1 NEW ORLEANS PERF H/L
MEDTRONIC, INC.
1G75R1
Not in Commercial Distribution

  • 00885074055466 ()


  • Cardiopulmonary bypass system blood tubing set
New - Ground Clip Lead Wire & Adaptor for Gentle Pulse™ & Digitest™ Pulptesters (Complies with New FDA Lead Wire Regulation)
PARKELL, INC.
D631ADAPT
Not in Commercial Distribution

  • M595D631ADAPT0 ()
D631ADAPT

  • Dental pulp analysis system
NEW METAL STRIPS Refill Package, #1000 Mesh C-Width Yellow
Gc America Inc.
000266
In Commercial Distribution

  • D0470002661 ()
000266

  • Dental abrasive strip, single-use
NEW METAL STRIPS Refill Package, #1000 Mesh B-Width Yellow
Gc America Inc.
000265
In Commercial Distribution

  • D0470002651 ()
000265

  • Dental abrasive strip, single-use
NEW METAL STRIPS Refill Package, #1000 Mesh A-Width Yellow
Gc America Inc.
000264
In Commercial Distribution

  • D0470002641 ()
000264

  • Dental abrasive strip, single-use
NEW METAL STRIPS Refill Package, #600 Mesh C-Width Green
Gc America Inc.
000262
In Commercial Distribution

  • D0470002621 ()
000262

  • Dental abrasive strip, single-use
NEW METAL STRIPS Refill Package, #600 Mesh B-Width Green
Gc America Inc.
000261
In Commercial Distribution

  • D0470002611 ()
000261

  • Dental abrasive strip, single-use
NEW METAL STRIPS Refill Package, #600 Mesh A-Width Green
Gc America Inc.
000260
In Commercial Distribution

  • D0470002601 ()
000260

  • Dental abrasive strip, single-use
NEW METAL STRIPS, Refill Package, #300 mesh C-Width Blue
Gc America Inc.
000258
In Commercial Distribution

  • D0470002581 ()
000258

  • Dental abrasive strip, single-use
NEW METAL STRIPS, Refill Package, #300 Mesh B-Width Blue
Gc America Inc.
000257
In Commercial Distribution

  • D0470002571 ()
000257

  • Dental abrasive strip, single-use
NEW METAL STRIPS Refill Package, #300 Mesh A-Width Blue
Gc America Inc.
000256
In Commercial Distribution

  • D0470002561 ()
000256

  • Dental abrasive strip, single-use
NEW METAL STRIPS Refill Package, #200 Mesh, C-Width Red
Gc America Inc.
000254
In Commercial Distribution

  • D0470002541 ()
000254

  • Dental abrasive strip, single-use
NEW METAL STRIPS Refill Package, #200 Mesh B-Width Red
Gc America Inc.
000253
In Commercial Distribution

  • D0470002531 ()
000253

  • Dental abrasive strip, single-use
Empty New Laryngoscope Box with Foam Insert Standard Handle
FLEXICARE MEDICAL LIMITED
040-377U
In Commercial Distribution

  • 05055788703938 ()


  • Rigid intubation laryngoscope, single-use
A film pack containing new films is loaded here.
FUJIFILM CORPORATION
DPX SMART TRAY : E
In Commercial Distribution

  • 04547410239355 ()


  • Diagnostic-imaging multiformat camera
New Fine Lock Tray Assort, set of 8 pcs
DENTECH CORPORATION
06040000
In Commercial Distribution

  • 04560218666215 ()


  • Dental impression tray, reusable
NEW METAL STRIPS Refill Package, #1000 Mesh C-Width Yellow
Gc America Inc.
000266
In Commercial Distribution

  • 14548161391764 ()
000266

  • Dental abrasive strip, single-use
NEW METAL STRIPS Refill Package, #1000 Mesh B-Width Yellow
Gc America Inc.
000265
In Commercial Distribution

  • 14548161391757 ()
000265

  • Dental abrasive strip, single-use
NEW METAL STRIPS Refill Package, #1000 Mesh A-Width Yellow
Gc America Inc.
000264
In Commercial Distribution

  • 14548161391740 ()
000264

  • Dental abrasive strip, single-use
NEW METAL STRIPS Refill Package, #600 Mesh C-Width Green
Gc America Inc.
000262
In Commercial Distribution

  • 14548161391726 ()
000262

  • Dental abrasive strip, single-use
NEW METAL STRIPS Refill Package, #600 Mesh B-Width Green
Gc America Inc.
000261
In Commercial Distribution

  • 14548161391719 ()
000261

  • Dental abrasive strip, single-use
NEW METAL STRIPS Refill Package, #600 Mesh A-Width Green
Gc America Inc.
000260
In Commercial Distribution

  • 14548161391702 ()
000260

  • Dental abrasive strip, single-use
NEW METAL STRIPS, Refill Package, #300 mesh C-Width Blue
Gc America Inc.
000258
In Commercial Distribution

  • 14548161391689 ()
000258

  • Dental abrasive strip, single-use
NEW METAL STRIPS, Refill Package, #300 Mesh B-Width Blue
Gc America Inc.
000257
In Commercial Distribution

  • 14548161391672 ()
000257

  • Dental abrasive strip, single-use
NEW METAL STRIPS Refill Package, #300 Mesh A-Width Blue
Gc America Inc.
000256
In Commercial Distribution

  • 14548161391665 ()
000256

  • Dental abrasive strip, single-use
NEW METAL STRIPS Refill Package, #200 Mesh, C-Width Red
Gc America Inc.
000254
In Commercial Distribution

  • 14548161391641 ()
000254

  • Dental abrasive strip, single-use
NEW METAL STRIPS Refill Package, #200 Mesh B-Width Red
Gc America Inc.
000253
In Commercial Distribution

  • 14548161391634 ()
000253

  • Dental abrasive strip, single-use
5 lb New Truliner PEMA P&L Kit Clear
Harry J Bosworth Company
0921990
In Commercial Distribution

  • H66809219901 ()
0921990

  • Denture reliner, hard
5 lb New Truliner PEMA P&L Kit Vein
Harry J Bosworth Company
0921989
In Commercial Distribution

  • H66809219891 ()
0921989

  • Denture reliner, hard
5 lb New Truliner PEMA P&L Kit Pink
Harry J Bosworth Company
0921988
In Commercial Distribution

  • H66809219881 ()
0921988

  • Denture reliner, hard
8 oz New Truliner PEMA P&L Kit Vein
Harry J Bosworth Company
0921971
In Commercial Distribution

  • H66809219711 ()
0921971

  • Denture reliner, hard
8 oz New Truliner PEMA P&L Kit Pink
Harry J Bosworth Company
0921970
In Commercial Distribution

  • H66809219701 ()
0921970

  • Denture reliner, hard
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