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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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Surround - 00812747010170

Surround version 5.x.x
HAEMONETICS CORPORATION
5.x.x
In Commercial Distribution

  • 00812747010170 ()


  • Blood bank information system application software

ProSpore2 - M985PS235501

Self-contained biological indicator for use in steam sterilization. Log 5. 50 count package.
MESA LABORATORIES, INC.
Log 5
Not in Commercial Distribution

  • M985PS235501 ()
  • M985PS235500 ()
PS2-3-5-50

  • Biological sterilization indicator

ProSpore2 - M985PS2351

Biological Indicator intended for steam sterilization (121C). Contains spores of Geobacillus stearothermophilus. 50 units / box
MESA LABORATORIES, INC.
Log 5
Not in Commercial Distribution

  • M985PS2351 ()
  • M985PS23550 ()
PS2-3-5-50

  • Biological sterilization indicator

SwissPlus® - 00889024016019

No Description
ZIMMER DENTAL INC.
OPT/5
In Commercial Distribution

  • 00889024016019 ()

  • Ø4.8mm, Ø5.2mm


  • Dental implant suprastructure, temporary, preformed, single-use

SwissPlus® - 00889024015739

No Description
ZIMMER DENTAL INC.
OPA/5
In Commercial Distribution

  • 00889024015739 ()

  • Ø4.8mm, Ø5.2mm


  • Dental implant suprastructure, temporary, preformed, single-use

Tapered Screw-Vent® - 00889024015326

No Description
ZIMMER DENTAL INC.
HLT4/5
In Commercial Distribution

  • 00889024015326 ()


  • Dental implant suprastructure, temporary, preformed, single-use

Tapered Screw-Vent® - 00889024015302

No Description
ZIMMER DENTAL INC.
HLT3/5
In Commercial Distribution

  • 00889024015302 ()

  • Ø3.5mm, Ø5.5mm


  • Dental implant suprastructure, temporary, preformed, single-use

Hex-Lock® - 00889024015210

No Description
ZIMMER DENTAL INC.
HLA4/5
In Commercial Distribution

  • 00889024015210 ()

  • Ø4.5mm, Ø5.5mm


  • Dental implant suprastructure, permanent, preformed

Hex-Lock® - 00889024015180

No Description
ZIMMER DENTAL INC.
HLA3/5
In Commercial Distribution

  • 00889024015180 ()

  • Ø3.5mm, Ø5.5mm


  • Dental implant suprastructure, permanent, preformed

Tapered Screw-Vent® - 00889024014619

No Description
ZIMMER DENTAL INC.
DHT4/5
In Commercial Distribution

  • 00889024014619 ()

  • Device Size Text, specify:


  • Dental implant suprastructure, temporary, preformed, single-use

Tapered Screw-Vent® - 00889024014596

No Description
ZIMMER DENTAL INC.
DHT3/5
In Commercial Distribution

  • 00889024014596 ()

  • Ø3.5mm; Ø5.5mm


  • Dental implant suprastructure, temporary, preformed, single-use

Tapered Screw-Vent® Implant System - 00889024013759

No Description
ZIMMER DENTAL INC.
AH20W/5
In Commercial Distribution

  • 00889024013759 ()

  • Ø4.5mm, Ø5.5mm


  • Dental implant suprastructure, permanent, preformed

NeuroSmart Autoclavable Drive Headstage Kit - 27290114060930

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Rev. 5
In Commercial Distribution

  • 27290114060930 ()
700-026008-00

  • Depth electrode

NeuroSmart with AutoClavable Drive Headstage - 27290114060916

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Rev. 5
In Commercial Distribution

  • 27290114060916 ()
NSW-006008-55

  • Depth electrode

NeuroNav with Autoclavable Drive Headstage - 27290114060909

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Rev. 5
In Commercial Distribution

  • 27290114060909 ()
NNW-006008-55

  • Depth electrode

MocareHealth - 26971384153942

Sterile Polyisoprene Powder-Free Surgical Gloves - Natural
Motex Healthcare(Anhui)Co.,Ltd.
7629S/5
In Commercial Distribution

  • 26971384153942 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 26971384153843

Sterile Polyisoprene Powder-Free Surgical Gloves - Natural
Motex Healthcare(Anhui)Co.,Ltd.
7621S/5
In Commercial Distribution

  • 26971384153843 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 26971384153744

Sterile Polyisoprene Powder-Free Surgical Gloves - Blue
Motex Healthcare(Anhui)Co.,Ltd.
7529F/5
In Commercial Distribution

  • 26971384153744 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 26971384153645

Sterile Polyisoprene Powder-Free Surgical Gloves - Blue
Motex Healthcare(Anhui)Co.,Ltd.
7521F/5
In Commercial Distribution

  • 26971384153645 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 26971384153546

Sterile Nitrile Accelerator-Free and Sulfur-Free Powder-Free Surgical gloves - Green
Motex Healthcare(Anhui)Co.,Ltd.
7729F/5
In Commercial Distribution

  • 26971384153546 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 26971384153447

Sterile Nitrile Accelerator-Free and Sulfur-Free Powder-Free Surgical gloves - Green
Motex Healthcare(Anhui)Co.,Ltd.
7721F/5
In Commercial Distribution

  • 26971384153447 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 26971384153348

Sterile Latex Powder-Free Surgical gloves - Brown
Motex Healthcare(Anhui)Co.,Ltd.
2921S/5
In Commercial Distribution

  • 26971384153348 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 26971384153249

Sterile Latex Powder-Free Surgical gloves - Brown
Motex Healthcare(Anhui)Co.,Ltd.
2829F/5
In Commercial Distribution

  • 26971384153249 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 26971384153140

Sterile Latex Powder-Free Surgical gloves - Brown
Motex Healthcare(Anhui)Co.,Ltd.
2821S/5
In Commercial Distribution

  • 26971384153140 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 26971384153041

Sterile Latex Powder-Free Surgical gloves - Natural
Motex Healthcare(Anhui)Co.,Ltd.
2729S/5
In Commercial Distribution

  • 26971384153041 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 26971384152945

Sterile Latex Powder-Free Surgical gloves
Motex Healthcare(Anhui)Co.,Ltd.
2729F/5
In Commercial Distribution

  • 26971384152945 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 26971384152846

Sterile Latex Powder-Free Surgical gloves
Motex Healthcare(Anhui)Co.,Ltd.
2721S/5
In Commercial Distribution

  • 26971384152846 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 26971384152747

Sterile Latex Powder-Free Surgical gloves
Motex Healthcare(Anhui)Co.,Ltd.
2721F/5
In Commercial Distribution

  • 36971384152744 ()
  • 26971384152747 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 26971384150842

Single-use sterile rubber surgical gloves
Motex Healthcare(Anhui)Co.,Ltd.
1610/5
In Commercial Distribution

  • 36971384150849 ()
  • 26971384150842 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

Coaxial Cannulae and Hand Pieces - 25056030402863

16/21g SO I/A H/P 90°
STERIMEDIX LIMITED
M5563-02/5
In Commercial Distribution

  • 15056030402866 ()
  • 25056030402863 ()
M5563

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Bimanual I/A Systems - 25056030401798

23g Twin Pack Irr/Asp
STERIMEDIX LIMITED
M5536-02/5
In Commercial Distribution

  • 15056030401791 ()
  • 25056030401798 ()
M5536

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Bimanual I/A Systems - 25056030401743

21g TW x 16m Bimanual
STERIMEDIX LIMITED
M5531-02/5
In Commercial Distribution

  • 15056030401746 ()
  • 25056030401743 ()
M5531

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Bimanual Cannulae and Hand Pieces - 25056030401712

21g x 5/8" Bimanual Irr
STERIMEDIX LIMITED
M5521-02/5
In Commercial Distribution

  • 15056030401715 ()
  • 25056030401712 ()
M5521

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Bimanual Cannulae and Hand Pieces - 25056030401682

23g x 5/8" Bimanual Asp
STERIMEDIX LIMITED
M5518-02/5
In Commercial Distribution

  • 35056030401689 ()
  • 25056030401682 ()
M5518

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Bimanual Cannulae and Hand Pieces - 25056030401651

23g x 5/8" Bimanual Irr
STERIMEDIX LIMITED
M5513-02/5
In Commercial Distribution

  • 45056030401655 ()
  • 25056030401651 ()
M5513

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Bimanual Cannulae and Hand Pieces - 25056030401613

21g x 5/8" Bimanual Irr
STERIMEDIX LIMITED
M5505-02/5
In Commercial Distribution

  • 15056030401616 ()
  • 25056030401613 ()
M5505

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

NeuroSmart Autoclavable Drive Headstage - 07290114060967

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Rev. 5
In Commercial Distribution

  • 07290114060967 ()
700-006008-00

  • Depth electrode

Prismaflex - 07332414105266

The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy.
GAMBRO AB
5.XX
Not in Commercial Distribution

  • 07332414105266 ()
113081

  • Haemodialysis system, institutional

MocareHealth - 36971384153840

Sterile Polyisoprene Powder-Free Surgical Gloves - Natural
Motex Healthcare(Anhui)Co.,Ltd.
7621S/5
In Commercial Distribution

  • 36971384153840 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 36971384153741

Sterile Polyisoprene Powder-Free Surgical Gloves - Blue
Motex Healthcare(Anhui)Co.,Ltd.
7529F/5
In Commercial Distribution

  • 36971384153741 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial
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