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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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mrdh Bandage 10 cm x 10 cm (4" x 4")
Marine Polymer Technologies, Inc.
400-14
In Commercial Distribution

  • 10389142000114 ()
  • 00389142000117 ()


  • Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial
No Description
SCIMEDX CORPORATION
I-EBV01X
In Commercial Distribution

  • 00813545025564 ()
I-EBV01X

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
Drägerwerk AG & Co. KGaA
8418458
In Commercial Distribution

  • 04048675028642 ()


  • Ventilator breathing circuit, reusable
No Description
Drägerwerk AG & Co. KGaA
8409634
In Commercial Distribution

  • 04048675028512 ()


  • Ventilator breathing circuit, reusable
No Description
Drägerwerk AG & Co. KGaA
8402041
In Commercial Distribution

  • 04048675026488 ()


  • Ventilator breathing circuit, reusable
No Description
Drägerwerk AG & Co. KGaA
2165600
Not in Commercial Distribution

  • 04048675023425 ()


  • Ventilator breathing circuit, reusable
No Description
Drägerwerk AG & Co. KGaA
2165848
In Commercial Distribution

  • 04048675014270 ()


  • Ventilator breathing circuit, reusable
No Description
Drägerwerk AG & Co. KGaA
8410709
In Commercial Distribution

  • 04048675010470 ()


  • Ventilator breathing circuit, reusable
S/ETCH JUMBO 2X25ML SYR
SDI LIMITED
8100059
In Commercial Distribution

  • 09336472012052 ()
8100059

  • Dental etching solution
S/ETCH 12GM SYR WITH TIPS
SDI LIMITED
8100052
In Commercial Distribution

  • 09336472012007 ()
8100052

  • Dental etching solution
S/ETCH 3X2ML SYR KT
SDI LIMITED
8100040
In Commercial Distribution

  • 09336472011932 ()
8100040

  • Dental etching solution
S/ETCH 10X2ML SYR KT
SDI LIMITED
8100045
In Commercial Distribution

  • 09336472011963 ()
8100045

  • Dental etching solution
MODEL 5004, 110V
ORMCO CORPORATION
973-0212
In Commercial Distribution

  • 00889989069532 ()


  • Endodontic filling material condenser
VITALITY SCANNER 2006
ORMCO CORPORATION
973-0234
Not in Commercial Distribution

  • 00889989069709 ()


  • Dental pulp analysis system
Heat Source, Model 1005
ORMCO CORPORATION
952-0001
In Commercial Distribution

  • 00889989068412 ()


  • Endodontic filling material condenser
ELEMENTS DIAGNOSTIC UNIT W/O SATELLITE
ORMCO CORPORATION
973-0320
In Commercial Distribution

  • 00889989061888 ()


  • Dental pulp analysis system
ELEMENTS DIAGNOSTIC UNIT
ORMCO CORPORATION
973-0300
In Commercial Distribution

  • 00889989061871 ()


  • Dental pulp analysis system
No Description
NEAUVIA NORTH AMERICA, INC.
300-1310
In Commercial Distribution

  • 00850017374171 ()


  • Radio-frequency skin/body contouring system
No Description
NEAUVIA NORTH AMERICA, INC.
300-1308
In Commercial Distribution

  • 00850017374164 ()


  • Radio-frequency skin/body contouring system
Foot switch for the Sectum System
NEAUVIA NORTH AMERICA, INC.
300-1306
In Commercial Distribution

  • 00850017374157 ()


  • Radio-frequency skin/body contouring system
No Description
NEAUVIA NORTH AMERICA, INC.
300-1301
In Commercial Distribution

  • 00850017374140 ()


  • Radio-frequency skin/body contouring system
No Description
NEAUVIA NORTH AMERICA, INC.
300-1302
In Commercial Distribution

  • 00850017374133 ()


  • Radio-frequency skin/body contouring system
No Description
NEAUVIA NORTH AMERICA, INC.
100-1301
In Commercial Distribution

  • 00850017374126 ()


  • Radio-frequency skin/body contouring system
The Puregraft Combined Adapter is an autoclavable, reusable medical device used for the transfer of soft tissue and fluid between syringes and Puregraft products during general surgical and plastic surgery procedures.
Bimini Technologies LLC
ADAPT/PURE
In Commercial Distribution

  • 00850034511016 ()


  • Collection syringe adaptor, reusable
No Description
STRADIS MEDICAL, LLC
570-3229
Not in Commercial Distribution

  • M75257032290 ()


  • Collection syringe adaptor, single-use
ALIF Modular Distractor Tip - 9mm
Seaspine Orthopedics Corporation
95-6193
In Commercial Distribution

  • 10889981189334 ()
95-6193

  • Collection syringe adaptor, single-use
ALIF Modular Distractor Tip - 8mm
Seaspine Orthopedics Corporation
95-6192
In Commercial Distribution

  • 10889981189327 ()
95-6192

  • Collection syringe adaptor, reusable
HANDPIECE, NXT (REFURB)
SOLTA MEDICAL
TH-2R
In Commercial Distribution

  • 00850608002902 ()
TH-2R

  • Radio-frequency skin/body contouring system
HANDPIECE, NXT, 16.0 (REFURB)
SOLTA MEDICAL
TH-3R
In Commercial Distribution

  • 00850608002896 ()
TH-3R

  • Radio-frequency skin/body contouring system
HANDPIECE, CPT (REFURB)
SOLTA MEDICAL
TH-4R
In Commercial Distribution

  • 00850608002889 ()
TH-4R

  • Radio-frequency skin/body contouring system
RETURN CABLE, THERMACOOL NXT
SOLTA MEDICAL
TP-2
In Commercial Distribution

  • 00850608002247 ()
TP-2

  • Radio-frequency skin/body contouring system
HANDPIECE, CPT
SOLTA MEDICAL
TH-4
In Commercial Distribution

  • 00850608002193 ()
TH-4

  • Radio-frequency skin/body contouring system
HANDPIECE, NXT 16.0
SOLTA MEDICAL
TH-3
In Commercial Distribution

  • 00850608002186 ()
TH-3

  • Radio-frequency skin/body contouring system
HANDPIECE, NXT
SOLTA MEDICAL
TH-2
In Commercial Distribution

  • 00850608002179 ()
TH-2

  • Radio-frequency skin/body contouring system
COUPLING FLUID 60ML
SOLTA MEDICAL
TF-2-60
In Commercial Distribution

  • 00850608002162 ()
TF-2-60

  • Radio-frequency skin/body contouring system
COUPLING FLUID, 30ML
SOLTA MEDICAL
TF-2-30
In Commercial Distribution

  • 00850608002155 ()
TF-2-30

  • Radio-frequency skin/body contouring system
COOLANT CANISTER, TC-2-4, 4PK
SOLTA MEDICAL
TC-2-4
In Commercial Distribution

  • 00850608002148 ()
TC-2-4

  • Radio-frequency skin/body contouring system
THERMACOOL TC COOLANT CANISTER 4PK
SOLTA MEDICAL
TC-1-4
In Commercial Distribution

  • 00850608002131 ()
TC-1-4

  • Radio-frequency skin/body contouring system
THERMACOOL, CPT
SOLTA MEDICAL
TG-2B
In Commercial Distribution

  • 00850608002124 ()
TG-2B

  • Radio-frequency skin/body contouring system
Viveve Return Cable
VIVEVE, INC.
VIVRC01
In Commercial Distribution

  • 00850794007194 ()
VIVRC01

  • Radio-frequency skin/body contouring system
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