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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Ambler cartridge injector, 6 1/4'', front loading cartridge, for use with AMO One series ultra cartridges, plunger mechanism, titanium
AMBLER SURGICAL CORP.
Ambler cartridge injector
In Commercial Distribution

  • 00190660205799 ()
7291T

  • Manual intraocular lens injector, reusable
Tolsdorf bone crusher
AMBLER SURGICAL CORP.
Tolsdorf bone crusher
In Commercial Distribution

  • 00190660112141 ()
43-108

  • Otologic clamp
Jost crusher/morselizer
AMBLER SURGICAL CORP.
Jost crusher/morselizer
In Commercial Distribution

  • 00190660112127 ()
45-710

  • Otologic clamp
Cottle cartilage crusher, 2 3/4'', 15.0mm wide, smooth bed
AMBLER SURGICAL CORP.
Cottle cartilage crusher
In Commercial Distribution

  • 00190660112066 ()
43-100

  • Otologic clamp
Ambler cartilage crusher, 60mm x 30mm
AMBLER SURGICAL CORP.
Ambler cartilage crusher
In Commercial Distribution

  • 00190660112035 ()
43-105

  • Otologic clamp
Sternal wire twister, 8'', serrated TC jaws, gold ring handle
AMBLER SURGICAL CORP.
Sternal wire twister
In Commercial Distribution

  • 00190660111960 ()
45-551

  • Suturing needle holder, reusable
Sternal wire twister, 7'', serrated TC jaws, gold ring handle
AMBLER SURGICAL CORP.
Sternal wire twister
In Commercial Distribution

  • 00190660111953 ()
45-550

  • Suturing needle holder, reusable
Berry wire twister, 8'', serrated TC jaws, gold ring handle
AMBLER SURGICAL CORP.
Berry wire twister
In Commercial Distribution

  • 00190660111878 ()
45-522

  • Suturing needle holder, reusable
Berry wire twister, 7 1/4'', serrated TC jaws, black ring handle
AMBLER SURGICAL CORP.
Berry wire twister
In Commercial Distribution

  • 00190660111861 ()
45-520

  • Suturing needle holder, reusable
Dingman wire passer, 6 1/2'', curved
AMBLER SURGICAL CORP.
Dingman wire passer
In Commercial Distribution

  • 00190660109455 ()
43-120

  • Wire/ligature passer, reusable
Crawford suture ring, 9'' diameter
AMBLER SURGICAL CORP.
Crawford suture ring
In Commercial Distribution

  • 00190660109349 ()
45-675

  • Gastro-urological guidewire, reusable
Berci fascial closure instrument, 17cm, size 2.8mm, ring handle
AMBLER SURGICAL CORP.
Berci fascial closure instrument
In Commercial Distribution

  • 00190660109318 ()
43-585

  • Gastro-urological guidewire, reusable
Universal chuck, 4'', fully cannulated, with t-handle, keyless chuck
AMBLER SURGICAL CORP.
Universal chuck
In Commercial Distribution

  • 00190660106201 ()
43-785

  • Surgical drill chuck
Steinmann pin chuck, 4'', fully cannulated, includes chuck key
AMBLER SURGICAL CORP.
Steinmann pin chuck
In Commercial Distribution

  • 00190660106188 ()
43-790

  • Surgical drill chuck
Uebe applicator, 7'', twist end
AMBLER SURGICAL CORP.
Uebe applicator
In Commercial Distribution

  • 00190660105853 ()
43-331

  • ENT probe, reusable
Uebe applicator, 7'', triangular end
AMBLER SURGICAL CORP.
Uebe applicator
In Commercial Distribution

  • 00190660105846 ()
43-330

  • ENT probe, reusable
Lathbury applicator, 6'', twist end
AMBLER SURGICAL CORP.
Lathbury applicator
In Commercial Distribution

  • 00190660105839 ()
43-321

  • ENT probe, reusable
Lathbury applicator, 6'', triangular end
AMBLER SURGICAL CORP.
Lathbury applicator
In Commercial Distribution

  • 00190660105822 ()
43-320

  • ENT probe, reusable
Farrell applicator, 5 1/2'', twist end
AMBLER SURGICAL CORP.
Farrell applicator
In Commercial Distribution

  • 00190660105815 ()
43-311

  • ENT probe, reusable
Farrell applicator, 5 1/2'', triangular end
AMBLER SURGICAL CORP.
Farrell applicator
In Commercial Distribution

  • 00190660105808 ()
43-310

  • ENT probe, reusable
Dean applicator, 6'', twist end
AMBLER SURGICAL CORP.
Dean applicator
In Commercial Distribution

  • 00190660105792 ()
43-301

  • ENT probe, reusable
Dean applicator, 6'', triangular end
AMBLER SURGICAL CORP.
Dean applicator
In Commercial Distribution

  • 00190660105785 ()
43-300

  • ENT probe, reusable
Capsular tension ring injector, 6 1/2'', curved shaft, hook pointed up, plunger mechanism, titanium, for use with Morcher CTR's
AMBLER SURGICAL CORP.
Capsular tension ring injector
In Commercial Distribution

  • 00190660089672 ()
7286T

  • Capsular tension ring inserter
Capsular tension ring injector, 6 1/2'', curved shaft, hook pointed down, plunger mechanism, titanium, for use with Ophtec/AMO CTR's
AMBLER SURGICAL CORP.
Capsular tension ring injector
In Commercial Distribution

  • 00190660089665 ()
7285T

  • Capsular tension ring inserter
Ambler III cartridge injector, 6 1/4'', front loading cartridge, for use with Alcon® Type D cartridges, screw mechanism, titanium
AMBLER SURGICAL CORP.
Ambler III cartridge injector
In Commercial Distribution

  • 00190660089658 ()
7283T

  • Manual intraocular lens injector, reusable
Ambler III cartridge injector, 5 3/4'', front loading cartridge, for use with Alcon® Type D cartridges, plunger mechanism, titanium
AMBLER SURGICAL CORP.
Ambler III cartridge injector
In Commercial Distribution

  • 00190660089641 ()
7284T

  • Manual intraocular lens injector, reusable
Ambler II cartridge injector, 6 1/4'', front loading cartridge, for use with Alcon® Type A, B & C cartridges, screw mechanism, titanium
AMBLER SURGICAL CORP.
Ambler II cartridge injector
In Commercial Distribution

  • 00190660089634 ()
7281T

  • Manual intraocular lens injector, reusable
Ambler II cartridge injector, 5 3/4'', front loading cartridge, for use with Alcon® Type A, B & C cartridges, plunger mechanism, titanium
AMBLER SURGICAL CORP.
Ambler II cartridge injector
In Commercial Distribution

  • 00190660089627 ()
7282T

  • Manual intraocular lens injector, reusable
No Description
Microport Orthopedics Inc.
APA00005
In Commercial Distribution

  • M684APA000051 ()
APA00005

  • Joint prosthesis implantation kit, reusable
No Description
Microport Orthopedics Inc.
8400CP02
In Commercial Distribution

  • M6848400CP021 ()
8400CP02

  • Joint prosthesis implantation kit, reusable
No Description
Microport Orthopedics Inc.
8400CP00
In Commercial Distribution

  • M6848400CP001 ()
8400CP00

  • Joint prosthesis implantation kit, reusable
No Description
Microport Orthopedics Inc.
84000000
In Commercial Distribution

  • M684840000001 ()
84000000

  • Joint prosthesis implantation kit, reusable
No Description
Microport Orthopedics Inc.
81000000
In Commercial Distribution

  • M684810000001 ()
81000000

  • Joint prosthesis implantation kit, reusable
Pulmonary Guidewire
BOSTON SCIENTIFIC CORPORATION
M00515170
In Commercial Distribution

  • 08714729455813 ()
  • 08714729745754 ()

  • 0.035 in Diameter
  • 180 cm Length


  • General-purpose non-vascular guidewire
No Description
Microport Orthopedics Inc.
83000000
In Commercial Distribution

  • M684830000001 ()
83000000

  • Joint prosthesis implantation kit, reusable
No Description
Microport Orthopedics Inc.
82000000
In Commercial Distribution

  • M684820000001 ()
82000000

  • Joint prosthesis implantation kit, reusable
The Needle-Holder is an instrument intended to hold the suturing needle for the closing of incisions. It locks when it grips the needle or thread. All non-glare, except for the closure mechanism. This instrument is usually not used at the same time as the laser.
Oculo-Plastik Inc
25-014R
Not in Commercial Distribution

  • 10697660003426 ()

  • Length: 14 Centimeter
  • Length: 5.5 Inch


  • Suturing needle holder, reusable
The Needle-Holder is an instrument intended to hold the suturing needle for the closing of incisions. It locks when it grips the needle or thread. All non-glare, except for the closure mechanism. This instrument is usually not used at the same time as the laser.
Oculo-Plastik Inc
25-014
In Commercial Distribution

  • 10697660003419 ()

  • Length: 5.5 Inch
  • Length: 14 Centimeter


  • Suturing needle holder, reusable
Duraholder 12.75 x 18/5 inch, 6 Pockets, 2 Rows with Slits, 100 Case; Instrument Holder
PRECISION DYNAMICS CORPORATION
Y5647883
In Commercial Distribution

  • 10687225799246 ()
  • 10687225799086 ()
PDC-DURA702/100

  • Personal device holder, single-use
Duraholder 6.25 x 12.25 inches, 1 Pocket, 100 Case; Instrument Holder
PRECISION DYNAMICS CORPORATION
Y5647882
In Commercial Distribution

  • 10687225799239 ()
  • 10687225799079 ()
PDC-DURA512/100

  • Personal device holder, single-use
Duraholder 5.5 x 5.25 inches, 1 Pocket, 100 Case; Instrument Holder
PRECISION DYNAMICS CORPORATION
Y5647881
In Commercial Distribution

  • 10687225799222 ()
  • 10687225799062 ()
PDC-DURA505/100

  • Personal device holder, single-use
Duraholder 16x18.5 inches 6 Pockets, 2 Rows, 100 Case; Instrument Holder
PRECISION DYNAMICS CORPORATION
Y5647879
In Commercial Distribution

  • 10687225799208 ()
  • 10687225799048 ()
PDC-DURA300/100

  • Personal device holder, single-use
Duraholder, 12.5X17.25 inch 6 Pockets, 2 Rows with Slits; Instrument Holder, 100 Case
PRECISION DYNAMICS CORPORATION
Y5647878
In Commercial Distribution

  • 10687225799192 ()
  • 10687225799031 ()
PDC-DURA102/100

  • Personal device holder, single-use
Duraholder, 12.5X17.5 inch 6 Pockets, 2 Rows; Instrument Holder, 100 Case
PRECISION DYNAMICS CORPORATION
Y5647877
In Commercial Distribution

  • 10687225799185 ()
  • 10687225799024 ()
PDC-DURA100/100

  • Personal device holder, single-use
AMSure® LIGHT HANDLE COVER CAUTION: Avoid freezing and excessive heat.
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 10704411011125 ()
  • 40704411011126 ()
  • 00704411011128 ()
LHC002

  • Medical equipment handle cover, single-use
MEDICAL GRADE STAINLESS STEEL COLANDER 8"
Peak Medical Distribution Inc.
33-SM Colander
In Commercial Distribution

  • G45333SMCOLANDAR0 ()


  • Dental root separator
NAIL PACK
MEDLINE INDUSTRIES, INC.
SUT15830A
In Commercial Distribution

  • 40653160996751 ()
  • 10653160996750 ()
SUT15830A

  • General surgical procedure kit, non-medicated, single-use
NAIL PACK
MEDLINE INDUSTRIES, INC.
MNS15210
In Commercial Distribution

  • 40653160995822 ()
  • 10653160995821 ()
MNS15210

  • General surgical procedure kit, non-medicated, single-use
TOENAIL EXCISION TRAY
MEDLINE INDUSTRIES, INC.
MNS15095
In Commercial Distribution

  • 40653160995174 ()
  • 10653160995173 ()
MNS15095

  • General surgical procedure kit, non-medicated, single-use
TOE NAIL KIT
MEDLINE INDUSTRIES, INC.
MNS15030
In Commercial Distribution

  • 40653160994665 ()
  • 10653160994664 ()
MNS15030

  • General surgical procedure kit, non-medicated, single-use
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