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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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Auvard 3.0lbs, 75° angle, Blade - M803030923

Auvard 3.0lbs, 75° angle, Blade 1 1/2" x 3 1/4" (38mm x 83mm)
MEDGYN PRODUCTS, INC.
Auvard 3.0lbs, 75° angle, Blade 1 1/2" x 3 1/4" (38mm x 83mm)
In Commercial Distribution

  • M803030923 ()
030923

  • Vaginal speculum, reusable

Auvard 2.5lbs, 75° angle, Blade - M803030922

Auvard 2.5lbs, 75° angle, Blade 11/2" x 31/4" (38mm x 83mm)
MEDGYN PRODUCTS, INC.
Auvard 2.5lbs, 75° angle, Blade 11/2" x 31/4" (38mm x 83mm)
In Commercial Distribution

  • M803030922 ()
030922

  • Vaginal speculum, reusable

Auvard 2.0lbs, 75° angle, Blade - M803030921

Auvard 2.0lbs, 75° angle, Blade 11/2" x3 1/4" (38mm x 83mm)
MEDGYN PRODUCTS, INC.
Auvard 2.0lbs, 75° angle, Blade 11/2" x 3 1/4" (38mm x 83mm)
In Commercial Distribution

  • M803030921 ()
030921

  • Vaginal speculum, reusable

Graves Moore Speculum - M803030920

Graves Moore Speculum 1 1/4" x 3 1/2" (32mm x 89mm)
MEDGYN PRODUCTS, INC.
Graves Moore Speculum 1 1/4" x 3 1/2" (32mm x 89mm)
In Commercial Distribution

  • M803030920 ()
030920

  • Vaginal speculum, reusable

Pederson Extra Long Snowman Clinton - M803030917

Pederson Extra Long Snowman Clinton 1" x 6" (25mm x 152mm)
MEDGYN PRODUCTS, INC.
Pederson Extra Long Snowman Clinton 1" x 6" (25mm x 152mm)
In Commercial Distribution

  • M803030917 ()
030917

  • Vaginal speculum, reusable

Pederson XLarge - M803030914

Pederson XLarge 1" x 61/2" (25mm x 165mm)
MEDGYN PRODUCTS, INC.
Pederson XLarge 1" x 61/2" (25mm x 165mm)
In Commercial Distribution

  • M803030914 ()
030914

  • Vaginal speculum, reusable

Pederson XSmall - M803030913

Pederson XSmall 1/2" x 2 3/4" (13mm x 70mm)
MEDGYN PRODUCTS, INC.
Pederson XSmall 1/2" x 2 3/4" (13mm x 70mm)
In Commercial Distribution

  • M803030913 ()
030913

  • Vaginal speculum, reusable

Weisman Graves Medium - M803030912

Weisman Graves Medium - Left Side Open 1 3/8" x 4" (35mm x 102mm)
MEDGYN PRODUCTS, INC.
Weisman Graves Medium - Left Side Open 1 3/8" x 4" (35mm x 102mm)
In Commercial Distribution

  • M803030912 ()
030912

  • Vaginal speculum, reusable

Weisman Graves Medium - Right Side Open - M803030911

Weisman Graves Medium - Right Side Open 1 3/8" x 4" (35mm x 102mm)
MEDGYN PRODUCTS, INC.
Weisman Graves Medium - Right Side Open 1 3/8" x 4" (35mm x 102mm)
In Commercial Distribution

  • M803030911 ()
030911

  • Vaginal speculum, reusable

Graves Wide Angled Medium Right Side Open - M803030910

Graves Wide Angled Medium Right Side Open 1 3/8" x 4" (35mm x 102mm)
MEDGYN PRODUCTS, INC.
Graves Wide Angled Medium Right Side Open 1 3/8" x 4" (35mm x 102mm)
In Commercial Distribution

  • M803030910 ()
030910

  • Vaginal speculum, reusable

Pederson Large - M803030908

Pederson Large 1" x 4 3/4" (25mm x 121mm)
MEDGYN PRODUCTS, INC.
Pederson Large 1" x 4 3/4" (25mm x 121mm)
In Commercial Distribution

  • M803030908 ()
030908

  • Vaginal speculum, reusable

Pederson Medium - M803030907

Pederson Medium 7/8" x 4" (22mm x 102mm)
MEDGYN PRODUCTS, INC.
Pederson Medium 7/8" x 4" (22mm x 102mm)
In Commercial Distribution

  • M803030907 ()
030907

  • Vaginal speculum, reusable

Pederson Small - M803030906

Pederson Small 1/2" x 3" (13mm x 76mm)
MEDGYN PRODUCTS, INC.
Pederson Small 1/2" x 3" (13mm x 76mm)
In Commercial Distribution

  • M803030906 ()
030906

  • Vaginal speculum, reusable

Graves Vu-Max Large - M8030030976

Graves Vu-Max Large 5" (127mm)
MEDGYN PRODUCTS, INC.
Graves Vu-Max Large 5" (127mm)
In Commercial Distribution

  • M8030030976 ()
030976

  • Vaginal speculum, reusable

PILLING - 14026704792204

SPEC RECTAL FANSLER
TELEFLEX INCORPORATED
IPN017908
In Commercial Distribution

  • 54026704792202 ()
  • 14026704792204 ()
P16365

  • Vaginal speculum, reusable

PILLING - 14026704791931

SPEC ENDOCERVICAL KOGAN
TELEFLEX INCORPORATED
IPN017768
In Commercial Distribution

  • 54026704791939 ()
  • 14026704791931 ()
P16078

  • Vaginal speculum, reusable

PILLING - 14026704791924

SPEC VAG O'SULLIVAN O'CONNER COMPLETE
TELEFLEX INCORPORATED
IPN017721
In Commercial Distribution

  • 54026704791922 ()
  • 14026704791924 ()
P15990

  • Vaginal speculum, reusable

PILLING - 14026704791917

SPEC VAG STEINER AUVARD 6"
TELEFLEX INCORPORATED
IPN017715
In Commercial Distribution

  • 54026704791915 ()
  • 14026704791917 ()
P15979

  • Vaginal speculum, reusable

PILLING - 14026704791900

GUGTMAN VAGINAL RETRACTOR XL
TELEFLEX INCORPORATED
IPN924064
In Commercial Distribution

  • 54026704791908 ()
  • 14026704791900 ()
P15961

  • Vaginal speculum, reusable

PILLING - 14026704791894

SPEC VAGINAL GUTTMAN FENE CT BLD 89X30MM
TELEFLEX INCORPORATED
IPN924063
In Commercial Distribution

  • 54026704791892 ()
  • 14026704791894 ()
P15960

  • Vaginal speculum, reusable

PILLING - 14026704791856

SPECULA DEVILBISS VAGINAL MED 4"X 1 1/4"
TELEFLEX INCORPORATED
IPN911950
In Commercial Distribution

  • 54026704791854 ()
  • 14026704791856 ()
P15894

  • Vaginal speculum, reusable

PILLING - 14026704791849

SPEC VAG PEDERSON MED
TELEFLEX INCORPORATED
IPN017676
In Commercial Distribution

  • 54026704791847 ()
  • 14026704791849 ()
P15881

  • Vaginal speculum, reusable

Marina Medical - 00840306830303

Nichols Vaginal Weighted Speculum, w/Suction, 2.5 Lbs. 2.75inx1.5in
MARINA MEDICAL INSTRUMENTS, INC.
350-180
In Commercial Distribution

  • 00840306830303 ()

  • Weight: 2.5 Pound
350-180

  • Vaginal speculum, reusable

Symmetry Steiner-Auvard - 00887482077474

Symmetry® Speculum, Steiner-Auvard Vaginal, 2.5 lbs
SYMMETRY SURGICAL INC.
52-2959
In Commercial Distribution

  • 00887482077474 ()

  • Weight: 2.5 Pound
52-2959

  • Vaginal speculum, reusable

Repaired Products - M803040060

Repaired Products
MEDGYN PRODUCTS, INC.
Repaired Products
In Commercial Distribution

  • M803040060 ()
040060

  • Vaginal speculum, reusable

Rotating Shaft - Tischler Tip - Down - M803030148

Rotating Shaft - Tischler Tip - Down
MEDGYN PRODUCTS, INC.
Rotating Shaft - Tischler Tip - Down
In Commercial Distribution

  • M803030148 ()
030148

  • Vaginal speculum, reusable

Rotating Shaft (w/any tip) - M803030100

Rotating Shaft (w/any tip)
MEDGYN PRODUCTS, INC.
Rotating Shaft (w/any tip)
In Commercial Distribution

  • M803030100 ()
030100

  • Vaginal speculum, reusable

PRINCETON - 00810158215450

SPECULUM AUVARD VAGINAL 105MM X 38MM WITH FIXED WEIGHT 1.4KG (3 LBS)
Princeton Medical Group, Inc.
71309-00
In Commercial Distribution

  • 00810158215450 ()


  • Vaginal speculum, reusable

i-ED COIL - 04540778190429

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
393-030530
In Commercial Distribution

  • 04540778190429 ()

  • Complex (Infini Silky Soft) 12inch 3-5mm x 30cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
393-030530

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778190412

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
390-0212
In Commercial Distribution

  • 04540778190412 ()

  • Complex (Silky Soft) 10inch 2mm x 12cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-0212

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177796

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
374-142450
In Commercial Distribution

  • 04540778177796 ()

  • Helical (Infini Standard) 17inch 14-24mm x 50cm
  • Compatible Microcatheter inner diameter: 0.48 to 0.53 Millimeter
374-142450

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177772

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
373-122050
In Commercial Distribution

  • 04540778177772 ()

  • Helical (Infini Standard) 14inch 12-20mm x 50cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
373-122050

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177734

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
373-051250
In Commercial Distribution

  • 04540778177734 ()

  • Helical (Infini Soft) 14inch 5-12mm x 50cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
373-051250

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177710

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
373-051230
In Commercial Distribution

  • 04540778177710 ()

  • Helical (Infini Soft) 14inch 5-12mm x 30cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
373-051230

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177659

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
373-040830
In Commercial Distribution

  • 04540778177659 ()

  • Helical (Infini Extra Soft) 14inch 4-8mm x 30cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
373-040830

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177635

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
373-040815
In Commercial Distribution

  • 04540778177635 ()

  • Helical (Infini Extra Soft) 14inch 4-8mm x 15cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
373-040815

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177628

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
373-040810
In Commercial Distribution

  • 04540778177628 ()

  • Helical (Infini Extra Soft) 14inch 4-8mm x 10cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
373-040810

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177611

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
372-041030
In Commercial Distribution

  • 04540778177611 ()

  • Helical (Infini Soft) 10inch 4-10mm x 30cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
372-041030

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177604

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
372-041020
In Commercial Distribution

  • 04540778177604 ()

  • Helical (Infini Soft) 10inch 4-10mm x 20cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
372-041020

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177550

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
371-041015
In Commercial Distribution

  • 04540778177550 ()

  • Helical (Infini Extra Soft) 10inch 4-10mm x 15cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
371-041015

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177543

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
371-041010
In Commercial Distribution

  • 04540778177543 ()

  • Helical (Infini Extra Soft) 10inch 4-10mm x 10cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
371-041010

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177321

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
393-030520
In Commercial Distribution

  • 04540778177321 ()

  • Complex (Infini Silky Soft) 12inch 3-5mm x 20cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
393-030520

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177314

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
393-030515
In Commercial Distribution

  • 04540778177314 ()

  • Complex (Infini Silky Soft) 12inch 3-5mm x 15cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
393-030515

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177291

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
393-030510
In Commercial Distribution

  • 04540778177291 ()

  • Complex (Infini Silky Soft) 12inch 3-5mm x 10cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
393-030510

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177284

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
393-020310
In Commercial Distribution

  • 04540778177284 ()

  • Complex (Infini Silky Soft) 12inch 2-3mm x 10cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
393-020310

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177260

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
393-020306
In Commercial Distribution

  • 04540778177260 ()

  • Complex (Infini Silky Soft) 12inch 2-3mm x 6cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
393-020306

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177253

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
393-020304
In Commercial Distribution

  • 04540778177253 ()

  • Complex (Infini Silky Soft) 12inch 2-3mm x 4cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
393-020304

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177246

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-1650
In Commercial Distribution

  • 04540778177246 ()

  • Complex (Standard) 14inch 16mm x 50cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
392-1650

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177239

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-1450
In Commercial Distribution

  • 04540778177239 ()

  • Complex (Standard) 14inch 14mm x 50cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
392-1450

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177222

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-1250
In Commercial Distribution

  • 04540778177222 ()

  • Complex (Medium Soft) 14inch 12mm x 50cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
392-1250

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
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