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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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AngioTouch® Kit - 10841716100175

Model AT P54, p/n 701278-002 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014644
Not in Commercial Distribution

  • 30841716100179 ()
  • 10841716100175 ()


  • Contrast medium injection system hand controller kit

AngioTouch® Kit - 10841716100168

Model AT P54, p/n 700608-042 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014644
Not in Commercial Distribution

  • 30841716100162 ()
  • 10841716100168 ()
  • 30841716101824 ()


  • Contrast medium injection system hand controller kit

AngioTouch® Kit - 10841716100151

Model AT P54, p/n 700608-041 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014644
Not in Commercial Distribution

  • 30841716100155 ()
  • 10841716100151 ()


  • Contrast medium injection system hand controller kit

AngioTouch® Kit - 10841716100144

Model AT P54, p/n 700608-040 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014644
Not in Commercial Distribution

  • 30841716100148 ()
  • 10841716100144 ()


  • Contrast medium injection system hand controller kit

AngioTouch® Kit - 10841716100137

Model AT P54, p/n 700608-039 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014644
Not in Commercial Distribution

  • 30841716100131 ()
  • 10841716100137 ()


  • Contrast medium injection system hand controller kit

AngioTouch® Kit - 10841716100120

Model AT P54, p/n 700608-035 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014644
Not in Commercial Distribution

  • 30841716100124 ()
  • 10841716100120 ()


  • Contrast medium injection system hand controller kit

AngioTouch® Kit - 10841716100090

Model AT L65, p/n 700608-026 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014643
Not in Commercial Distribution

  • 30841716100094 ()
  • 10841716100090 ()


  • Contrast medium injection system hand controller kit

Bone Molder - Offset - 00083208130137

Bone molder - used to compress bone in between dental Implants at time of placement - Offset to allow access to posterior
Suncoast Dental, Inc
Bone Molder - Offset
In Commercial Distribution

  • 00083208130137 ()
Bone Molder - Offset

  • Osteotomy compression/distraction instrument

Integra® Miltex® - 10381780417934

Integra® Miltex® Iris Tissue Forceps 3-7/8", Standard, Full Curved, 1 x 2 Teeth, 0.8mm wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-790
In Commercial Distribution

  • H834187900 ()
  • 10381780417934 ()
18-790

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Integra® Miltex® - 10381780417910

Integra® Miltex® Iris Tissue Forceps 3-7/8", Standard, Half Curved, 1 x 2 Teeth, 0.8mm wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-788
In Commercial Distribution

  • H834187880 ()
  • 10381780417910 ()
18-788

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Nova - D79010601051

Nova Nitrile Powder-Free, X-Large, Super-stretchy nitrile, Textured fingertips, Very durable, Violet-blue in color, Packaging contains at least 70% recycled material
PURELIFE, LLC
1060105
In Commercial Distribution

  • D79010601053 ()
  • D79010601051 ()
  • D79010601050 ()
1060105

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Nova - D79010601041

Nova Nitrile Powder-Free, Large, Super-stretchy nitrile, Textured fingertips, Very durable, Violet-blue in color, Packaging contains at least 70% recycled material
PURELIFE, LLC
1060104
In Commercial Distribution

  • D79010601043 ()
  • D79010601041 ()
  • D79010601040 ()
1060104

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Nova - D79010601031

Nova Nitrile Powder-Free, Medium, Super-stretchy nitrile, Textured fingertips, Very durable, Violet-blue in color, Packaging contains at least 70% recycled material
PURELIFE, LLC
1060103
In Commercial Distribution

  • D79010601033 ()
  • D79010601031 ()
  • D79010601030 ()
1060103

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Nova - D79010601021

Nova Nitrile Powder-Free, Small, Super-stretchy nitrile, Textured fingertips, Very durable, Violet-blue in color, Packaging contains at least 70% recycled material
PURELIFE, LLC
1060102
In Commercial Distribution

  • D79010601023 ()
  • D79010601021 ()
  • D79010601020 ()
1060102

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Nova - D79010601011

Nova Nitrile Powder-Free, X-Small, Super-stretchy nitrile, Textured fingertips, Very durable, Violet-blue in color, Packaging contains at least 70% recycled material
PURELIFE, LLC
1060101
In Commercial Distribution

  • D79010601013 ()
  • D79010601011 ()
  • D79010601010 ()
1060101

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Surgical Direct - B382S345563000

Pre-op Toric Reference Marker, Half Circle With 3 Points At 0, 90 and 180 Degrees On A Round Knurled Handle
Surgical Direct, Inc.
S34556.300
In Commercial Distribution

  • B382S345563000 ()
S34556.300

  • Intraocular retractor, reusable

Pointe Scientific, Inc - 00811727012432

ISE Standard - High For the standardization of Sodium, Potassium and Chloride on Ion Selective Electrodes. packaged at 10 x 2ml
POINTE SCIENTIFIC, INC.
HI790-STH
In Commercial Distribution

  • 00811727012432 ()
HI790-STH

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

Pointe Scientific - 00811727012425

ISE Standard - Low For the standardization of Sodium, Potassium and Chloride on Ion Selective Electrodes. packaged at 10 x 2ml
POINTE SCIENTIFIC, INC.
HI790-STL
In Commercial Distribution

  • 00811727012425 ()
HI790-STL

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

Integra® Miltex® - 10381780488088

Integra® Miltex® Sims Rectal Speculum, 6", Fenestrated Blades, 3-1/2" Deep x 5/8" Wide At Distal End
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
MH28-2
In Commercial Distribution

  • H834MH2820 ()
  • 10381780488088 ()
MH28-2

  • Rectal speculum

Titan - 00817914020426

Scoville-Greenwood Bayonet Bipolar Forcep 7 3/4" (196.85mm) Insulated With A With A 0.25mm Tip (*** PRODUCT MAY SCISSOR AT TIPS ***)
TITAN MANUFACTURING INC
162018239010101
In Commercial Distribution

  • 00817914020426 ()

  • Length: 196.85 Millimeter


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Ambler Surgical - 00190660122744

Cottle osteotome, 7 1/4'', straight, 9.0mm wide, with markings at 4.0cm, 5.0cm, 6.0cm and 7.0cm, rounded corners, flat handle
AMBLER SURGICAL CORP.
Cottle osteotome
In Commercial Distribution

  • 00190660122744 ()
59-354

  • Plastic surgery osteotome

Ambler Surgical - 00190660122737

Cottle osteotome, 7 1/4'', straight, 6.0mm wide, with markings at 4.0cm, 5.0cm, 6.0cm and 7.0cm, rounded corners, flat handle
AMBLER SURGICAL CORP.
Cottle osteotome
In Commercial Distribution

  • 00190660122737 ()
59-352

  • Plastic surgery osteotome

Ambler Surgical - 00190660122720

Cottle osteotome, 7 1/4'', straight, 4.0mm wide, with markings at 4.0cm, 5.0cm, 6.0cm and 7.0cm, rounded corners, flat handle
AMBLER SURGICAL CORP.
Cottle osteotome
In Commercial Distribution

  • 00190660122720 ()
59-350

  • Plastic surgery osteotome

Ambler Surgical - 00190660122713

Cottle osteotome, 7 1/4'', straight, 20.0mm wide, with markings at 4.0cm, 5.0cm, 6.0cm and 7.0cm, rounded corners, flat handle
AMBLER SURGICAL CORP.
Cottle osteotome
In Commercial Distribution

  • 00190660122713 ()
59-360

  • Plastic surgery osteotome

Ambler Surgical - 00190660122706

Cottle osteotome, 7 1/4'', straight, 14.0mm wide, with markings at 4.0cm, 5.0cm, 6.0cm and 7.0cm, rounded corners, flat handle
AMBLER SURGICAL CORP.
Cottle osteotome
In Commercial Distribution

  • 00190660122706 ()
59-358

  • Plastic surgery osteotome

Ambler Surgical - 00190660122690

Cottle osteotome, 7 1/4'', straight, 12.0mm wide, with markings at 4.0cm, 5.0cm, 6.0cm and 7.0cm, rounded corners, flat handle
AMBLER SURGICAL CORP.
Cottle osteotome
In Commercial Distribution

  • 00190660122690 ()
59-356

  • Plastic surgery osteotome

Ambler Surgical - 00190660122683

Cottle osteotome, 7 1/4'', curved, 6.0mm wide, with markings at 4.0cm, 5.0cm, 6.0cm and 7.0cm, rounded corners, flat handle
AMBLER SURGICAL CORP.
Cottle osteotome
In Commercial Distribution

  • 00190660122683 ()
59-353

  • Nasal chisel

Ambler Surgical - 00190660122676

Cottle osteotome, 7 1/4'', curved, 4.0mm wide, with markings at 4.0cm, 5.0cm, 6.0cm and 7.0cm, rounded corners, flat handle
AMBLER SURGICAL CORP.
Cottle osteotome
In Commercial Distribution

  • 00190660122676 ()
59-351

  • Nasal chisel

Resp-O2 Heat Moisture Exchanger (HME) 1500, Adult, HCH, CO2 Port - 00840117305434

Tidal Volume Range(150-1500mL) Media(Foam), Dead Space(34mL), Breathing Resistance(2.8cm H2O at 60 L/min), Weight(15g), Adult
Dynarex Corporation
30203
In Commercial Distribution

  • 00840117305441 ()
  • 00840117305434 ()


  • Heat/moisture exchanger/microbial medical gas filter

ASP MEDICAL - 00840216106697

COVERALL, DISPOSABLE, WHITE, 3XLARGE, ELASTIC CUFF, OPEN ANKLE, BACK ELASTIC AT LUMBAR, SMS 35GSM, 5EA/BG, 10BG/CS (50EA/CS)
Asp Global, LLC
GNTW505
In Commercial Distribution

  • 00840216106697 ()


  • Surgical coverall

ASP MEDICAL - 00840216106680

COVERALL, DISPOSABLE, WHITE, 2XLARGE, ELASTIC CUFF, OPEN ANKLE, BACK ELASTIC AT LUMBAR, SMS 35GSM, 5EA/BG, 10BG/CS (50EA/CS)
Asp Global, LLC
GNTW504
In Commercial Distribution

  • 00840216106680 ()


  • Surgical coverall

ASP MEDICAL - 00840216106673

COVERALL, DISPOSABLE, WHITE, XLARGE, ELASTIC CUFF, OPEN ANKLE, BACK ELASTIC AT LUMBAR, SMS 35GSM, 5EA/BG, 10BG/CS (50EA/CS)
Asp Global, LLC
GNTW503
In Commercial Distribution

  • 00840216106673 ()


  • Surgical coverall

Phaco Choppers - 08175700137973

Chaya Double Ended Chopper, Triple Edged Chopper With Polisher Tip (Verges Style)/Modified Axe Chopper, Offset at 90 Degree, RHD
AURORA SURGICAL, LLC
AS9-052R
In Commercial Distribution

  • 08175700137973 ()
AS9-052R

  • Ophthalmic surgical probe, reusable

Phaco Choppers - 08175700138727

Chaya Double Ended Chopper, Triple Edged Chopper With Polisher Tip (Verges Style)/Modified Axe Chopper, Offset at 90 Degree, LHD
AURORA SURGICAL, LLC
AS9-052L
In Commercial Distribution

  • 08175700138727 ()
AS9-052L

  • Ophthalmic surgical probe, reusable

Ambler Surgical - 00190660076122

Troutman-Barraquer colibri corneal forceps, 2 7/8'', 0.3mm 1x2 teeth set at 45 degrees, 6.0mm tying platforms, flat handle, titanium
AMBLER SURGICAL CORP.
Troutman-Barraquer colibri corneal forceps
In Commercial Distribution

  • 00190660076122 ()
2223T

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Ambler Surgical - 00190660075354

Thorpe corneal fixation forceps, 3 3/4'', straight shafts, 0.6mm 2x3 teeth set at 90 degrees, tying platforms, flat handle
AMBLER SURGICAL CORP.
Thorpe corneal fixation forceps
In Commercial Distribution

  • 00190660075354 ()
2272E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Kirwan - 00841019122136

Reusable Bipolar Forceps with Tip Angled Down 45 Degrees at 3mm, Insulate to the Angle, and 6" Working Length (Special)
KIRWAN SURGICAL PRODUCTS LLC
12-1436AUS
In Commercial Distribution

  • 00841019122136 ()


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Millennium - 00190776388430

Harms-Colibri Forceps, very delicate, 1x2 teeth, set at 45°, 0.12mm, 6mm tying platform, oval hole flat handle, 75mm OL, Titanium
Avalign Technologies, Inc.
92-F1450T
In Commercial Distribution

  • 00190776388430 ()


  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

JOBST Elvarex - 04019702281354

Elvarex 2/Thigh high without foot/Knee Comfort/Thigh high slip form without volant to sew at body bandage/Black
BSN-Jobst GmbH
79447-00039-00
In Commercial Distribution

  • 04019702281354 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable

JOBST Elvarex - 04019702279696

Elvarex 2/Thigh high without foot/Knee Comfort/Thigh high slip form without volant to sew at body bandage/Black
BSN-Jobst GmbH
79444-00041-00
In Commercial Distribution

  • 04019702279696 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
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