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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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CORTAC® - 00650551062844

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111TX-16-066
In Commercial Distribution

  • 00650551062844 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111TX-16-066

  • Cortical electrode

CORTAC® - 00650551062837

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-16-066
In Commercial Distribution

  • 00650551062837 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111-16-066

  • Cortical electrode

CORTAC® - 00650551062769

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111TX-16-062
In Commercial Distribution

  • 00650551062769 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111TX-16-062

  • Cortical electrode

CORTAC® - 00650551062752

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-16-062
In Commercial Distribution

  • 00650551062752 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2111-16-062

  • Cortical electrode

CORTAC® - 00650551074670

SUBDURAL STRIP ELECTRODE, PLATINUM, 8 CONTACT, 1X8, RADIOPAQUE "L" AT CONTACT #1 & #8, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-08-093-NS
In Commercial Distribution

  • 00650551074670 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.76 Millimeter
2110-08-093-NS

  • Cortical electrode

CORTAC® - 00650551050100

SUBDURAL STRIP ELECTRODE, PLATINUM, 8 CONTACT, 1X8, RADIOPAQUE "L" AT CONTACT #1 & #8, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-08-093
In Commercial Distribution

  • 00650551050100 ()

  • Thickness 0.76 Millimeter
  • Contact Diameter 3 Millimeter
2110-08-093

  • Cortical electrode

Hayden Medical - 00840319707715

St. Mark's Deep Pelvic Fiber-Optic Retractor, hollow handle, 7" narrow version tapers to 3-1/2cm's at tip with lip (universal connection)
Hayden Medical, Inc.
240-585L
In Commercial Distribution

  • 00840319707715 ()
240-585L

  • Hand-held surgical retractor, reusable

Ambler Surgical - 00190660058647

Katzin-Barraquer colibri corneal utility forceps, 2 7/8'', 0.5mm 1x2 teeth set at 45 degrees with 7.5mm tying platforms, flat handle
AMBLER SURGICAL CORP.
Katzin-Barraquer colibri corneal utility forceps
In Commercial Distribution

  • 00190660058647 ()
2239E

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

Ambler Surgical - 00190660057008

Hyde colibri corneal forceps, 4 1/4'', 0.12mm 2x2 teeth set at 45 degrees, with 7.0mm tying platform, flat 3-hole handle
AMBLER SURGICAL CORP.
Hyde colibri corneal forceps
In Commercial Distribution

  • 00190660057008 ()
9522E

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

Ambler Surgical - 00190660055615

Harms colibri forceps, 3'', very delicate 0.12mm, 1x2 teeth set at 45 degrees, 6.0mm TC dusted tying platform, flat handle, titanium
AMBLER SURGICAL CORP.
Harms colibri forceps
In Commercial Distribution

  • 00190660055615 ()
2364T

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

Ambler Surgical - 00190660055592

Harms colibri forceps, 2 3/4'', very delicate 0.2mm, 1x2 teeth set at 45 degrees, 5.0mm tying platform, flat handle, titanium
AMBLER SURGICAL CORP.
Harms colibri forceps
In Commercial Distribution

  • 00190660055592 ()
9510T

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

Ambler Surgical - 00190660054168

Girard corneoscleral forceps, 4 1/4'', right hand use, 0.12mm 1x2 teeth set at 90 degrees, 6.0mm tying platforms, round handle
AMBLER SURGICAL CORP.
Girard corneoscleral forceps
In Commercial Distribution

  • 00190660054168 ()
2345E

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

Ambler Surgical - 00190660054151

Girard corneoscleral forceps, 4 1/4'', left hand use, 0.3mm 1x2 teeth set at 90 degrees, 6.0mm tying platforms, round handle
AMBLER SURGICAL CORP.
Girard corneoscleral forceps
In Commercial Distribution

  • 00190660054151 ()
2342E

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

Ambler Surgical - 00190660054144

Girard corneoscleral forceps, 4 1/4'', left hand use, 0.12mm 1x2 teeth set at 90 degrees, 6.0mm tying platforms, round handle
AMBLER SURGICAL CORP.
Girard corneoscleral forceps
In Commercial Distribution

  • 00190660054144 ()
2344E

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

Ambler Surgical - 00190660075347

Thorpe corneal fixation forceps, 3 3/4'', straight shafts, 0.12mm 2x3 teeth set at 45 degrees and tying platforms, flat handle
AMBLER SURGICAL CORP.
Thorpe corneal fixation forceps
In Commercial Distribution

  • 00190660075347 ()
2275E

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

Hayden Medical - 00840319726747

Bechert-McPherson Tying Forceps, angled 10.5mm at 45 degree, with 10mm smooth tying platform, serrated flat handle, 84mm overall length, stainless steel
Hayden Medical, Inc.
E5-6104
In Commercial Distribution

  • 00840319726747 ()
E5-6104

  • Dressing/utility forceps, tweezers-like, reusable

Jay - 00016958052015

The JAY J3 wheelchair cushion provides outstanding stability and optimal pressure distribution for the client at high risk of skin breakdown.
SUNRISE MEDICAL (US) LLC
J3
In Commercial Distribution

  • 00016958052015 ()
E2622, E2623, E2624, E2625

  • Gel-filled chair cushion
  • Air-filled chair cushion

Titan - 00817914021287

M-Style Straight Bipolar Forcep 6 3/4" (171.45mm) With A With A 0.2mm Tip With Stop (*** PRODUCT MAY SCISSOR AT TIPS ***)
TITAN MANUFACTURING INC
163210131000101
In Commercial Distribution

  • 00817914021287 ()

  • Length: 171.45 Millimeter


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

PCRopsis - B55022761000

PCRopsis™ BCS Nano (100 mL) is intended for selective precipitation of red blood cells from whole blood at room temperature.
ENTOPSIS, LLC
BCS Nano
Not in Commercial Distribution

  • B55022761000 ()
2276100

  • Red blood cell separation reagent

PCRopsis - B550227610000

PCRopsis™ BCS Nano (1000 mL) is intended for selective precipitation of red blood cells from whole blood at room temperature.
ENTOPSIS, LLC
BCS Nano
Not in Commercial Distribution

  • B550227610000 ()
22761000

  • Red blood cell separation reagent

PCRopsis - B55022760100

PCRopsis™ BCS Nano (10 mL) is intended for selective precipitation of red blood cells from whole blood at room temperature.
ENTOPSIS, LLC
BCS Nano
Not in Commercial Distribution

  • B55022760100 ()
2276010

  • Red blood cell separation reagent

Rumex - 00840159904053

Utrata Capsulorhexis Forceps With Scale (2 Engravings At 3.00, 6.00 mm), Cystotome Tips, Curved Jaws, Round Handle, Length 110 mm, Titanium
RUMEX INTERNATIONAL CORP.
4-03314T
In Commercial Distribution

  • 00840159904053 ()
4-03314T

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

Rumex - 00840159904039

Utrata Capsulorhexis Forceps With Scale (2 Engravings at 3.00, 6.00 mm), Cystotome Tips, Straight jaws, Round Handle, Length 110 mm, Titanium
RUMEX INTERNATIONAL CORP.
4-03114T
In Commercial Distribution

  • 00840159904039 ()
4-03114T

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

Ambler Surgical - 00190660041793

Bonn suturing forceps, 2 7/8'', straight shafts, 0.12mm 1x2 teeth set at 90 degrees, 5.0mm tying platforms, narrow handle, titanium
AMBLER SURGICAL CORP.
Bonn suturing forceps
In Commercial Distribution

  • 00190660041793 ()
2266T

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

Ambler Surgical - 00190660042936

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

  • 00190660042936 ()
2233T

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

Ambler Surgical - 00190660041915

Bores corneal fixation forceps, 4 3/8'', straight shafts, u-shaped, 3.0mm spread, 0.12mm 1x2 teeth at each tip, flat 3-hole handle
AMBLER SURGICAL CORP.
Bores corneal fixation forceps
In Commercial Distribution

  • 00190660041915 ()
9551E

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

MR PHACO - G412PH24430

TTI-McPherson Tying Forceps Angled 10.5mm at 45 Degree, with 10mm Smooth Tying Platform, Round Knurled Handle, 105mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH2443
In Commercial Distribution

  • G412PH24430 ()


  • Ophthalmic surgical device handling forceps, reusable

BR Surgical, LLC - 00840183516789

SIMS Specula Set, double ended, (3 each)
BR Surgical, LLC
BR70-29100
In Commercial Distribution

  • 00840183516789 ()
BR70-29100

  • Vaginal speculum, reusable

BR Surgical, LLC - 00840183516116

SIMS Vaginal Speculum, large, 1 3/8" x 3 1/2"
BR Surgical, LLC
BR70-28103
In Commercial Distribution

  • 00840183516116 ()
BR70-28103

  • Vaginal speculum, reusable

BR Surgical, LLC - 00840183516086

SIMS Vaginal Speculum, small, 1" x 2 1/2"
BR Surgical, LLC
BR70-28101
In Commercial Distribution

  • 00840183516086 ()
BR70-28101

  • Vaginal speculum, reusable
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