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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Healon/Viscoelastic Injection Cannula 27ga, Flattened Round Tip, Angled 5mm from bend to tip at 40 degree, 29mm Overall Length
Crestpoint Management Limited
CA1426
In Commercial Distribution

  • G412CA14260 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Healon/Viscoelastic Injection Cannula 19ga, Flattened Round Tip, Angled 5mm from bend to tip at 40 degree, 29mm Overall Length
Crestpoint Management Limited
CA1425
In Commercial Distribution

  • G412CA14250 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Healon/Viscoelastic Injection Cannula 18ga, Flattened Round Tip, Angled 5mm from bend to tip at 40 degree, 29mm Overall Length
Crestpoint Management Limited
CA1424
In Commercial Distribution

  • G412CA14240 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
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
Maumenee vitreous aspirating needle, 18 gauge, straight, markings at 10.0mm, 15.0mm and 20.0mm from tip, 25.0mm overall length excluding hub
AMBLER SURGICAL CORP.
Maumenee vitreous aspirating needle
In Commercial Distribution

  • 00190660005962 ()
1066E

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Lewicky cortex extractor cannula, 23 gauge, curved, 0.3mm aspiration port set at 45 degrees right, 13.0mm overall length excluding hub
AMBLER SURGICAL CORP.
Lewicky cortex extractor cannula
In Commercial Distribution

  • 00190660005856 ()
1102E

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Lewicky cortex extractor cannula, 23 gauge, curved, 0.3mm aspiration port set at 45 degrees left, 13.0mm overall length excluding hub
AMBLER SURGICAL CORP.
Lewicky cortex extractor cannula
In Commercial Distribution

  • 00190660005849 ()
1103E

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
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
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
Harms colibri forceps, 3'', very delicate 0.12mm, 1x2 teeth set at 45 degrees, 6.0mm TC dusted tying platform, flat handle
AMBLER SURGICAL CORP.
Harms colibri forceps
In Commercial Distribution

  • 00190660055608 ()
2364E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Harms colibri corneal utility forceps, 2 3/4'', 0.12mm 1x2 teeth set at 45 degrees, 4.5mm tying platforms, flat handle
AMBLER SURGICAL CORP.
Harms colibri corneal utility forceps
In Commercial Distribution

  • 00190660055585 ()
2230E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
LRI economy diamond knife, straight, 1.00mm wide, tri-facet blade, dull sides, single footplate, preset at 600 microns, j-slot aluminum handle
AMBLER SURGICAL CORP.
LRI economy diamond knife
In Commercial Distribution

  • 00190660028992 ()
21-236E

  • Ophthalmic knife, reusable
Castroviejo colibri corneal forceps, 4 1/4'', 0.12mm 1x2 teeth set at 45 degrees, 6.0mm tying platforms, wide flat handle
AMBLER SURGICAL CORP.
Castroviejo colibri corneal forceps
In Commercial Distribution

  • 00190660042929 ()
2233E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Bonn suturing forceps, 2 7/8'', straight shafts, 0.12mm 1x2 teeth set at 90 degrees, 5.0mm tying platforms, narrow handle
AMBLER SURGICAL CORP.
Bonn suturing forceps
In Commercial Distribution

  • 00190660041786 ()
2266E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Maumenee cross-action colibri corneal forceps, 4 3/4'', 0.1mm 1x2 teeth set at 90 degrees, 5.0mm tying platforms, flat handle
AMBLER SURGICAL CORP.
Maumenee cross-action colibri corneal forceps
In Commercial Distribution

  • 00190660063528 ()
2232E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Maumenee cross-action colibri corneal forceps, 4 3/4'', 0.1mm 1x2 teeth set at 45 degrees, 5.0mm tying platforms, flat handle
AMBLER SURGICAL CORP.
Maumenee cross-action colibri corneal forceps
In Commercial Distribution

  • 00190660063511 ()
2231E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Model AT P54, p/n 700608-055 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

  • 30841716102135 ()
  • 10841716102131 ()


  • Contrast medium injection system hand controller kit
Model AT P65, p/n 701677-001 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014645
In Commercial Distribution

  • 30841716102005 ()
  • 10841716102001 ()


  • Contrast medium injection system hand controller kit
Model AT P54, p/n 701675-001 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014644
In Commercial Distribution

  • 30841716101992 ()
  • 10841716101998 ()


  • Contrast medium injection system hand controller kit
Model AT P54, p/n 700608-054 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

  • 30841716101930 ()
  • 10841716101936 ()


  • Contrast medium injection system hand controller kit
Model AT P54, p/n 701278-008 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

  • 10841716101394 ()
  • 30841716101398 ()


  • Contrast medium injection system hand controller kit
Model AT L65, p/n 700633-003 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

  • 30841716101381 ()
  • 10841716101387 ()


  • Contrast medium injection system hand controller kit
Model AT R54, p/n 700632-003 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014646
Not in Commercial Distribution

  • 30841716101374 ()
  • 10841716101370 ()


  • Contrast medium injection system hand controller kit
Model AT P65, p/n 701564-010 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014645
Not in Commercial Distribution

  • 30841716101367 ()
  • 10841716101363 ()


  • Contrast medium injection system hand controller kit
Model AT P54, p/n 700608-049 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

  • 30841716101350 ()
  • 10841716101356 ()


  • Contrast medium injection system hand controller kit
Model AT P65, p/n 701564-008 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014645
Not in Commercial Distribution

  • 30841716101312 ()
  • 10841716101318 ()


  • Contrast medium injection system hand controller kit
Model AT P54, p/n 700608-048 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

  • 30841716101305 ()
  • 10841716101301 ()


  • Contrast medium injection system hand controller kit
Model AT P54, p/n 700608-047 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

  • 30841716101299 ()
  • 10841716101295 ()


  • Contrast medium injection system hand controller kit
Model AT P54, p/n 700608-046 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

  • 30841716101282 ()
  • 10841716101288 ()


  • Contrast medium injection system hand controller kit
Model AT P65, p/n 701564-002 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014645
Not in Commercial Distribution

  • 30841716100780 ()
  • 10841716100786 ()


  • Contrast medium injection system hand controller kit
Model AT P54, p/n 700608-052 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

  • 30841716100353 ()
  • 10841716100359 ()


  • Contrast medium injection system hand controller kit
Model AT R54, p/n 700608-025 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014646
Not in Commercial Distribution

  • 30841716100247 ()
  • 10841716100243 ()


  • Contrast medium injection system hand controller kit
Model AT P65, p/n 701564-001 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014645
Not in Commercial Distribution

  • 30841716100230 ()
  • 10841716100236 ()


  • Contrast medium injection system hand controller kit
Model AT P65, p/n 701554-002 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014645
Not in Commercial Distribution

  • 30841716100223 ()
  • 10841716100229 ()


  • Contrast medium injection system hand controller kit
Model AT P65, p/n 701554-001 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014645
Not in Commercial Distribution

  • 30841716100216 ()
  • 10841716100212 ()


  • Contrast medium injection system hand controller kit
Model AT P54, p/n 701278-006 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

  • 10841716100199 ()
  • 30841716100193 ()


  • Contrast medium injection system hand controller kit
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
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
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
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
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
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
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
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 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 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 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 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
Elvarex 2/Thigh high without foot/Knee Comfort/Thigh high slip form without volant to sew at body bandage/Navy
BSN-Jobst GmbH
79447-00083-00
In Commercial Distribution

  • 04019702466034 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Thigh high without foot/Knee Comfort/Thigh high slip form without volant to sew at body bandage/Navy
BSN-Jobst GmbH
79444-00088-00
In Commercial Distribution

  • 04019702465303 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
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