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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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
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
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
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
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
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™ 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™ 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
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
Integra Peritoneal Open-Ended Catheter With Slits PERITONEAL CATHETER, 90CM LENGTH 12 mm H2O at a flow rate of 23 ml/hr.
Integra Lifesciences Corporation
NL98003S01
In Commercial Distribution

  • 10381780072546 ()
  • M269NL98003S011 ()

  • Tubing: 1.3mm ID x 2.5mm OD; Total Length: 90 cm (35 1/2") (All dimensions nominal)
NL98003S01

  • Peritoneal/atrial cerebrospinal fluid catheter
Pre-op Toric Reference Marker, Titanium, Half Circle With 3 Points At 0, 90 and 180 Degrees On A Round Knurled Handle
Surgical Direct, Inc.
S34556.300T
In Commercial Distribution

  • B382S34556300T0 ()
S34556.300T

  • Intraocular retractor, reusable
3 1/2" Utrata Forceps, Short 3-Hole Handle, Laser Lines at 2.5mm and 5.0mm, 12mm Bend to Tip, Delicate Triangular Tips
Surgical Direct, Inc.
S2853.000
In Commercial Distribution

  • B382S28530000 ()
S2853.000

  • Dressing/utility forceps, scissors-like, reusable
Dissection of vitreoretinal membranes using viscoelastic fluid. 30 gauge tip, 5mm long and angled at 45 degrees. Extension tube length 20cm.
HURRICANE MEDICAL INC
7519
In Commercial Distribution

  • 10813465011705 ()
  • 00813465011708 ()

  • Length: 33 Millimeter
  • Needle Gauge: 20 Gauge
7519

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Dissection of vitreoretinal membranes using viscoelastic fluid. 30 gauge tip, 5mm long and angled at 70 degrees. Extension tube length 20cm.
HURRICANE MEDICAL INC
7518
In Commercial Distribution

  • 10813465011699 ()
  • 00813465011692 ()

  • Length: 33 Millimeter
  • Needle Gauge: 20 Gauge
7518

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Dissection of vitreoretinal membranes using viscoelastic fluid. 30 gauge tip, 5mm long and angled at 90 degrees. Extension tube length 20cm.
HURRICANE MEDICAL INC
7517
In Commercial Distribution

  • 10813465011682 ()
  • 00813465011685 ()

  • Length: 33 Millimeter
  • Needle Gauge: 20 Gauge
7517

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
The Neotech Bridge is a breastfeeding assistance device intended to deliver supplemental nutrition to an infant latched at the breast/chest.
Neotech Products LLC
Kit – Bridge with Extension and 20ML & 60ML Syringes
In Commercial Distribution

  • 00812594013478 ()
N8001-Kit

  • Breast pump support kit, reusable
The Oxygen Demand Valve provides 100% oxygen to patients suffering from respiratory distress at the flow rate demanded by the patient.
O-Two Medical Technologies Inc
01DV3000
In Commercial Distribution

  • 07540195020115 ()
  • 07540195020122 ()

  • Weight: 0.20 Kilogram
  • Height: 3.1 Inch
  • Outer Diameter: 2.0 Inch
01DV3000

  • Demand valve
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
Tidal Volume Range(250-1500mL), Media(Foam), Dead Space(90mL), Breathing Resistance (1.6cm H2O at 60 L/min), Weight(15.5g). Adult/Pediatric
Dynarex Corporation
30202
In Commercial Distribution

  • 00840117318083 ()
  • 00840117318090 ()


  • Heat/moisture exchanger, single-use
Adult/Ped: Tidal Volume Range(300-1500mL), Breathing Resistance(1.8cm H2O at 60L/min, Media(Corrugated Paper), Dead Space(15mL), Weight(8.4g)
Dynarex Corporation
30309
In Commercial Distribution

  • 00840117305892 ()
  • 00840117305885 ()


  • Heat/moisture exchanger, single-use
Pediatric, Tidal Volume Range(70-600mL), Media(Foam + Flat Media), Dead Space(19mL), Breathing Resistance(1.6cm H2O at 30L /min), Weight(19g)
Dynarex Corporation
30107
In Commercial Distribution

  • 00840117305380 ()
  • 00840117305373 ()


  • Heat/moisture exchanger/microbial medical gas filter
Adult, Tidal Volume Range( 150-1000mL), Media (Foam+ Flat Media), Dead Space (43mL), Breathing Resistance (1.9cm H2O at 60L /min), Weight (21g)
Dynarex Corporation
30104
In Commercial Distribution

  • 00840117305328 ()
  • 00840117305311 ()


  • Heat/moisture exchanger/microbial medical gas filter
Pediatric, Tidal Volume Range(70-600mL), Media(Foam), Dead Space(21mL), Breathing Resistance(2.2cm H2O at 60 L/min), Weight(9g), Pediatric
Dynarex Corporation
30205
In Commercial Distribution

  • 00840117305489 ()
  • 00840117305472 ()


  • Heat/moisture exchanger/microbial medical gas filter
The Neotech Bridge is a breastfeeding assistance device intended to deliver supplemental nutrition to an infant latched at the breast/chest.
Neotech Products LLC
Bridge Only - 5pcs
In Commercial Distribution

  • 00812594012600 ()
  • 10812594012607 ()
N8001-5

  • Breast pump support kit, reusable
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
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
St Mark's Deep Retractor, 9" blade angled 15° at tip, narrow with lip, fiberoptic, Doyen handle, narrow version tapers to 3.5cm
Avalign Technologies, Inc.
63-G6110FO
In Commercial Distribution

  • 00190776384784 ()


  • Hand-held surgical retractor, reusable
Elvarex Forte 3/Thigh high without foot/Knee Comfort/Thigh high slip form without volant to sew at body bandage/Black
BSN-Jobst GmbH
79497-00016-00
In Commercial Distribution

  • 04019702278941 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 4 Super/Thigh high without foot/Knee Comfort/Thigh high slip form without volant to sew at body bandage/Black
BSN-Jobst GmbH
79496-00010-00
In Commercial Distribution

  • 04019702276756 ()

  • Pressure: >49 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 3/Thigh High/Slant, Open Toe, E-Version, Knee Comfort/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77567-01062-00
In Commercial Distribution

  • 04019702276169 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 3/Thigh High/Slant, Closed Toe, E-Version, Knee Comfort/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77567-01042-00
In Commercial Distribution

  • 04019702275582 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 3/Thigh High/Slant, Open Toe, Knee Comfort/Thigh high slip form without volant to sew at body bandage/Black
BSN-Jobst GmbH
77567-00917-00
In Commercial Distribution

  • 04019702274493 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 3/Thigh High/Slant, Closed Toe, Knee Comfort/Thigh high slip form without volant to sew at body bandage/Black
BSN-Jobst GmbH
77567-00893-00
In Commercial Distribution

  • 04019702273953 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 3/Thigh High/Closed Toe, E-Version, Knee Comfort/Thigh high slip form without volant to sew at body bandage/Black
BSN-Jobst GmbH
77567-00943-00
In Commercial Distribution

  • 04019702273458 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 3/Thigh High/Open Toe, E-Version, Knee Comfort/Thigh high slip form without volant to sew at body bandage/Black
BSN-Jobst GmbH
77567-00963-00
In Commercial Distribution

  • 04019702273250 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
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
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
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
Elvarex 3/Thigh High/Slant, Closed Toe, Knee Comfort/Thigh high slip form without volant to sew at body bandage/Cocoa
BSN-Jobst GmbH
77567-02186-00
In Commercial Distribution

  • 04019702412444 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Thigh High/Slant, Open Toe, Knee Comfort/Thigh high slip form without volant to sew at body bandage/Cocoa
BSN-Jobst GmbH
77556-02393-00
In Commercial Distribution

  • 04019702403909 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
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