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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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Frontal Sinus Rasp by Wigand strong pattern Ø 3 mm
FENTEX medical GmbH
418210FX
In Commercial Distribution

  • 04250407733865 ()
418210FX

  • Frontal sinus file/rasp
Antrum Rasp by Watson-Williams slightly curved, blunt 23 cm
FENTEX medical GmbH
408600FX
In Commercial Distribution

  • 04250407733063 ()
408600FX

  • Frontal sinus file/rasp
Kocher Bladder Spatula 23.5cm
RZ-Medizintechnik GmbH
320-175-235
In Commercial Distribution

  • 04049197263870 ()
320-175-235

  • Bladder spatula
Legueu Bladder Spatula 26.0cm
RZ-Medizintechnik GmbH
320-170-260
In Commercial Distribution

  • 04049197263863 ()
320-170-260

  • Bladder spatula
Integra® Miltex® Wiener Antrum Rasp, No. 3, Large, Trocar Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
20-382
In Commercial Distribution

  • H834203820 ()
  • 10381780421870 ()

  • 7-3/4"
  • Width: 5 Millimeter
20-382

  • Frontal sinus file/rasp
Integra® Miltex® Wiener Antrum Rasp, No. 2, Medium, Trocar Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
20-380
In Commercial Distribution

  • H834203800 ()
  • 10381780421863 ()

  • Width: 4 Millimeter
  • 7-3/4"
20-380

  • Frontal sinus file/rasp
Integra® Miltex® Wiener Antrum Rasp, No. 1, Small, Trocar Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
20-378
In Commercial Distribution

  • H834203780 ()
  • 10381780421856 ()

  • 7-3/4"
  • Width: 3 Millimeter
20-378

  • Frontal sinus file/rasp
No Description
Société Chirurgicale Instrumentarium Inc
s.50.055
In Commercial Distribution

  • 00810055472031 ()


  • Frontal sinus file/rasp
No Description
Société Chirurgicale Instrumentarium Inc
s.50.724
In Commercial Distribution

  • 00810055472222 ()


  • Frontal sinus file/rasp
No Description
Société Chirurgicale Instrumentarium Inc
s.50.090
In Commercial Distribution

  • 00810055472048 ()


  • Frontal sinus file/rasp
No Description
Société Chirurgicale Instrumentarium Inc
L.70.922
In Commercial Distribution

  • 00810055471713 ()


  • Frontal sinus file/rasp
MINI COMPRESSION DRIVER
Smith & Nephew, Inc.
211910
In Commercial Distribution

  • 00885556869017 ()
211910

  • Frontal sinus file/rasp
The Gravity Compensating Accessory (GCA) is designed to counterbalance gravity’s effects on the fluid column within the drainage catheter of an implanted shunt system. The GCA consists of a silicone elastomer encased stainless steel housing with a ruby ball held in a stainless steel seat (in the vertical orientation) by two to four stainless steel balls. In the horizontal orientation, a minimal resistance to flow (<30mmH2O at 5ml/h) is added to the system, and in the vertical orientation: 140-170, 200-250 or 260-320mmH2O (at 5ml/h).
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
903440
Not in Commercial Distribution

  • 10381780033530 ()
  • M2729034401 ()

  • High Pressure Range, Additional Resistance to Flow at 5ml/h, Horizontal Orientation < 30mmH2O, Vertical Orientation: 260-320mmH2O
903440

  • Ventriculo-peritoneal/atrial shunt
Gravity Compensating Accessory, High Pressure Range (Brown)
NATUS MEDICAL INCORPORATED
NT903440
In Commercial Distribution


  • High Pressure Range, Additional Resistance to Flow at 5ml/h, Horizontal Orientation < 30mmH2O, Vertical Orientation: 260-320mmH2O
NT903440

  • Ventriculo-peritoneal/atrial shunt
No Description
Zimmer, Inc.
3318
In Commercial Distribution

  • 00889024066397 ()

  • 3 mm X 15 mm Cup Size, Tapered to 4 mm at Rear, 30 Deg. Angulated


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Bow Tie,Adult : Tidal Volume Range(75-1500mL), Media(Corrugated Paper), Dead Space(12mL), Breathing Resistance(0.2cm H2O at 30L/min), Weight(4.8g)
Dynarex Corporation
30305
In Commercial Distribution

  • 00840117318120 ()
  • 00840117318137 ()


  • Heat/moisture exchanger, single-use
Standard protection: • It holds back loose hair from the face • There are 2 ties at the back to secure the cap firmly
HYGITECH
HY-50013
In Commercial Distribution

  • 03615140003254 ()
  • 03615140003247 ()
HY-50013

  • Medical equipment/instrument drape, single-use
T-Shape, Suction Port, Adult, Tidal Volume Range(150-1250mL), Media(Foam),Dead Space(15mL), Breathing Resistance(0.2cm H2O at 30L/min), Weight(5.5g)
Dynarex Corporation
30301
In Commercial Distribution

  • 00840117305533 ()
  • 00840117305540 ()


  • Heat/moisture exchanger/microbial medical gas filter
Adult, Tidal Volume Range(250-1500 mL), Media (Foam + Flat Media), Dead Space (60mL), Breathing Resistance (1.8cm H2O at 60L /min), Weight (36g)
Dynarex Corporation
30105
In Commercial Distribution

  • 00840117305342 ()
  • 00840117305335 ()


  • Heat/moisture exchanger/microbial medical gas filter
20 cm Radiopaque Straight Ventricular Catheter with large holes and graphite based length marks at 5, 10, 15 cm from the tip.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
901302
Not in Commercial Distribution

  • 10381780033332 ()
  • M2729013021 ()

  • Vent. Cath. 20cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Introducer 22cm Length
901302

  • Intracerebral infusion/drainage catheter, short-term
Gimbel Nucleus Spatula, .25mm Diameter, Angled 10mm from bend to tip at 30°, Smooth, Round knurled Handle, 109mm total length, Stainless Steel
Diamatrix
H308-S
In Commercial Distribution

  • 00813059017444 ()
H308-S

  • Ocular hook/spatula/manipulator, reusable
Bechert-McPherson Tying Forceps, Angled 10.5mm from bend to tip at 45°, 10mm smooth tying platform, Flat serrated handle, 84mm total length, Stainless
Diamatrix
F805S
In Commercial Distribution

  • 00813059017437 ()
F805S

  • Suturing needle holder, reusable
LED Light Therapy Device. Uses 1820 LEDs at 633nm to treat facial wrinkles. Available for use in Salons, Spas, Med Spas, Dermatology.
Medtek Lighting Corporation
Poly Pro Rejuv
In Commercial Distribution

  • B3437000A2 ()


  • Blue/red/infrared phototherapy lamp
For the calibration of the K-ASSAY® Alpha-1 AG, Alpha-1 AT, Complement C3, Comlement C4, Haptoglobin, IgA, IgG, IgM, and Transferrin assays.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-016C
In Commercial Distribution

  • 00816426020566 ()
KAI-016C

  • Plasma protein IVD, calibrator
Henderson Style Pre-Op Reference Marker, Half Circle With 3 Blunt Alignment Pins At 0, 90 and 180 Degrees, With Round Knurled Handle
Surgical Direct, Inc.
S34016.200
In Commercial Distribution

  • B382S340162000 ()
S34016.200

  • Intraocular retractor, reusable
FIBER OPTIC DEEP PELVIC RETRACTOR WITH DOYAN HANDLE, OVERALL BLADE LENGTH 9" (228MM) X 2.5" (65MM) WIDE AT TOP, 2" (55MM) WIDE
ELMED INCORPORATED
15-09-70F
In Commercial Distribution

  • 00198506081866 ()
15-09-70F

  • Hand-held surgical retractor, reusable
  • Fibreoptic retractor handle
fischer tonsil knife & dissector, 15.0 mm curved blade w/ sharp edge at flat tip, top edge serrated, 8 1/2" (21.5 cm)
NOVO SURGICAL, INC.
E8331-81
In Commercial Distribution

  • 00842331140518 ()
E8331-81

  • Skin grafting knife
Cottle Chisel Curved 6mm Wide Cutting Edge With Centimeter Marking At 4mm / 5mm / 6mm and 7mm Overall Length 7 1/4" (184mm)
Med Saver, Inc.
114-5456
In Commercial Distribution

  • 00194613060619 ()


  • Orthopaedic chisel
Cottle Osteotome Curved 4mm Wide Cutting Edge With Centimeter Marking At 4cm / 5cm / 6cm and 7cm Overall Length 7 1/4" (184mm)
Med Saver, Inc.
114-5447
In Commercial Distribution

  • 00194613047726 ()


  • Orthopaedic osteotome
Grene Visual Axis Marker With Smooth And Flat Handle, 1.5mm Bend At Tip, And An Overall Length Of 4 1/2"" (115mm)
Med Saver, Inc.
11-4-9212
In Commercial Distribution

  • 00194613042073 ()


  • Corneal marker, reusable
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