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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16x16 Premium Thermal - NiTi - Euro - U
Acme Monaco Corporation
AMC1616UMAREU
In Commercial Distribution

  • D972AMC1616UMAREU2 ()
  • AMC1616UMAREU0 ()


  • Orthodontic archwire
16x16 Premium Thermal - NiTi - Nat - U
Acme Monaco Corporation
AMC1616UMAR
In Commercial Distribution

  • D972AMC1616UMAR2 ()
  • AMC1616UMAR0 ()


  • Orthodontic archwire
COMPOSITE NB TESCERA - U / BEAM GUIDE
Power Dental U.S.A. Inc.
5120
In Commercial Distribution

  • D9435120 ()
5120

  • Margin finishing dental file/rasp, reusable
  • Dental amalgam carrier
  • Dental spatula, reusable
CHP BASIC G U PACK BCS
MEDLINE INDUSTRIES, INC.
DYNJ02671D
In Commercial Distribution

  • 10889942343041 ()
DYNJ02671D

  • General surgical procedure kit, non-medicated, reusable
CUSTOM PACK CB0M94R11 U OF IL
MEDTRONIC, INC.
CB0M94R11
Not in Commercial Distribution

  • 00643169842847 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM G U T S TRAY
Cardinal Health 200, LLC
32-1395C
In Commercial Distribution

  • 50888439507940 ()
  • 10888439507942 ()
32-1395C

  • General surgical procedure kit, medicated
CUSTOM PACK CB0M94R9 U OF IL
MEDTRONIC, INC.
CB0M94R9
Not in Commercial Distribution

  • 00613994634757 ()


  • Cardiopulmonary bypass system blood tubing set
AWL TAP EX0512319 4.0MM-4.5MM U JOINT
MEDTRONIC SOFAMOR DANEK, INC.
EX0512319
In Commercial Distribution

  • 00643169212237 ()


  • Bone awl, reusable
Headrest Cover U/W Mh07 Yellow
JENX LIMITED
COVH4-09
In Commercial Distribution

  • 05056235203933 ()


  • Medical cushion cover
T U R ADD ON PACK
MEDLINE INDUSTRIES, INC.
DYNJ45492A
In Commercial Distribution

  • 10889942184880 ()
DYNJ45492A

  • General surgical procedure kit, non-medicated, reusable
CUSTOM PACK CB0M94R12 U OF IL
MEDTRONIC, INC.
CB0M94R12
In Commercial Distribution

  • 00643169904545 ()


  • Cardiopulmonary bypass system blood tubing set
ATHERECTOMY THS-LX-C TURBOHAWK ATK HEC U
MEDTRONIC, INC.
THS-LX-C
In Commercial Distribution

  • 00643169968400 ()

  • Max. Guidewire .36 MM
  • Outer Diameter: 2.7 Millimeter
  • Length: 104.0 Centimeter
  • Catheter Gauge: 7.0 French


  • Mechanical atherectomy system catheter, peripheral
ATHERECTOMY THS-SX-C TURBOHAWK BTK HEC U
Covidien LP
THS-SX-C
In Commercial Distribution

  • 00643169968226 ()

  • Catheter Gauge: 6.0 French
  • Length: 129.0 Centimeter
  • Outer Diameter: 2.2 Millimeter
  • Max. Guidewire .36 MM


  • Mechanical atherectomy system catheter, peripheral
U H S NEURO PACK SC
MEDLINE INDUSTRIES, INC.
DYNJ07952J
In Commercial Distribution

  • 10889942607952 ()
  • 40889942607953 ()
DYNJ07952J

  • General surgical procedure kit, non-medicated, single-use
U S C T BIOPSY TRAY
Cardinal Health 200, LLC
MNU12BPSH9
In Commercial Distribution

  • 50888439060025 ()
  • 10888439060027 ()
MNU12BPSH9

  • General surgical procedure kit, medicated
U Series Angled Long "AM" Attachment
STRYKER CORPORATION
5100010072
Not in Commercial Distribution

  • 04546540074546 ()
5100-010-072

  • Drilling power tool attachment, basic
U Series Straight Long "AM" Attachment
STRYKER CORPORATION
5100010070
Not in Commercial Distribution

  • 04546540074539 ()
5100-010-070

  • Drilling power tool attachment, basic
U Series Angled Medium "M" Attachment
STRYKER CORPORATION
5100010052
Not in Commercial Distribution

  • 04546540074508 ()
5100-010-052

  • Drilling power tool attachment, basic
U Series Straight Medium "M" Attachment
STRYKER CORPORATION
5100010050
Not in Commercial Distribution

  • 04546540074492 ()
5100-010-050

  • Drilling power tool attachment, basic
U Series Angled Short "O" Attachment
STRYKER CORPORATION
5100010022
Not in Commercial Distribution

  • 04546540074454 ()
5100-010-022

  • Drilling power tool attachment, basic
U Series Straight Short "O" Attachment
STRYKER CORPORATION
5100010020
Not in Commercial Distribution

  • 04546540074447 ()
5100-010-020

  • Drilling power tool attachment, basic
U SU DMND CURETTAGE 878K 16C
COLTENE/WHALEDENT INC
XU878KC016
Not in Commercial Distribution

  • D661XU878KC0161 ()
  • D661XU878KC0160 ()


  • Carbide dental bur, reusable
LM Inicia DTS U, Intrasulcular knife
LM-Dental
171-172ESTU
In Commercial Distribution

  • 06438311707839 ()


  • Periodontal knife
LM Tunella DTS U, Tunneling knife
LM-Dental
175-177ESTU
In Commercial Distribution

  • 06438311707624 ()


  • Periodontal knife
Teflon Packer 1.2 mm DTS U
LM-Dental
470-480ESTU
In Commercial Distribution

  • 06438311707433 ()


  • Manual dental burnisher, reusable
LM Build-up Shaper DD DTS U
LM-Dental
352-353DDESTU
In Commercial Distribution

  • 06438311707396 ()


  • Manual dental burnisher, reusable
Enamel Chisel 1.2 mm DTS U
LM-Dental
132-133ESTU
In Commercial Distribution

  • 06438311707334 ()


  • Dental excavator, reusable
SharpJack SD DTS U, Scaler, Periodontics
LM-Dental
315-316SDESTU
In Commercial Distribution

  • 06438311213101 ()


  • Manual dental scaler, reusable
LM-Syntette SD DTS U, Curette, Periodontics
LM-Dental
215-216SDESTU
In Commercial Distribution

  • 06438311208824 ()


  • Periodontal curette
Plastic Ligature Applicator DTS U, Orthodontics
LM-Dental
416-417ESTU
In Commercial Distribution

  • 06438311045375 ()


  • Orthodontic ligature director
Plastic instrument, anterior DTS U, Restoration
LM-Dental
43-47DDESTU
In Commercial Distribution

  • 06438311038117 ()


  • Dental spatula, reusable
Excess Scaler Mini DTS U, Restoration
LM-Dental
784-794ESTU
In Commercial Distribution

  • 06438311037950 ()


  • Margin finishing dental file/rasp, reusable
Modeller MH Mini DTS U, Restoration
LM-Dental
707-708ESTU
In Commercial Distribution

  • 06438311037080 ()


  • Manual dental burnisher, reusable
Multiholder PK I DTS U, Restoration
LM-Dental
750-756ESTU
In Commercial Distribution

  • 06438311036410 ()


  • Manual dental burnisher, reusable
Spoon Excavator 1.5mm DTS U, Restoration
LM-Dental
533-534ESTU
In Commercial Distribution

  • 06438311035345 ()


  • Dental excavator, reusable
Plastic instrument, anterior DTS U, Restoration
LM-Dental
43-47ESTU
In Commercial Distribution

  • 06438311033440 ()


  • Dental spatula, reusable
Nyström I DTS U, Carver, Restoration
LM-Dental
74-75ESTU
In Commercial Distribution

  • 06438311030692 ()


  • Dental restoration carver, resin
Furcation Diamond File DTS U, Periodontics
LM-Dental
261-262DESTU
In Commercial Distribution

  • 06438311021867 ()


  • Periodontal curette
Diamond File mes-dist DTS U, Periodontics
LM-Dental
263-264DESTU
In Commercial Distribution

  • 06438311021850 ()


  • Periodontal curette
Hoe Scaler, posterior DTS U, Periodontics
LM-Dental
156-157ESTU
In Commercial Distribution

  • 06438311021829 ()


  • Periodontal hoe
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