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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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Fukasaku phaco chopper & Lieberman phaco spatula, 5 1/2'', double-ended, angled shafts, 10.0mm from bend to tip, wedge-shaped flat interior cutting edge, blunt tip, with notch for engaging the iris, microfinger chopper, blunt tip, for use in the left hand, round handle
AMBLER SURGICAL CORP.
Fukasaku phaco chopper & Lieberman phaco spatula
In Commercial Distribution

  • 00190660012083 ()
6866E

  • Ocular hook/spatula/manipulator, reusable
Sensor Pads are intended for use with Lucerno Dynamics sensors on clean, dry, intact skin. The sensor side adhesive is not intended for skin contact. Factors that may impact pad performance include lotion or other skin products, patient movement, and substantial body hair. Sensor Pads consist of a double-coated, two-in-one medical grade silicone adhesive and acrylic tape. The silicone adhesive is hypoallergenic and atraumatic upon removal; it is intended for attachment to the skin. The acrylic tape is intended for attachment to the plastic case of the sensor.
LUCERNO DYNAMICS, LLC
091220-018
In Commercial Distribution

  • 00850014578145 ()
  • 00850014578138 ()
091220-018

  • Hypoallergenic skin adhesive tape
Apligraf is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full thickness skin ulcers due to venous insufficience of greater than one month duration and which have not adequately responded to conventional ulcer therapy. Apligraf is also indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three weeks duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
ORGANOGENESIS INC.
1
In Commercial Distribution

  • 00618474000008 ()


  • Skin regeneration template, human-/animal-derived
2" SEAT EXTENSION KIT FOR TRAV L3 300LB 20" SEAT WIDTH (INCLUDES 2 TUBES, NYLON EXTENSION AND 2 DUST CAPS)
GF HEALTH PRODUCTS, INC.
90763SE20
In Commercial Distribution

  • M36890763SE201 ()
90763SE20

  • Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
2" SEAT EXTENSION KIT FOR TRAV L3 300LB 18" SEAT WIDTH (INCLUDES 2 TUBES, NYLON EXTENSION AND 2 DUST CAPS)
GF HEALTH PRODUCTS, INC.
90763SE18
In Commercial Distribution

  • M36890763SE181 ()
90763SE18

  • Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
2" SEAT EXTENSION KIT FOR TRAV L3 300LB 16" SEAT WIDTH (INCLUDES 2 TUBES, NYLON EXTENSION AND 2 DUST CAPS)
GF HEALTH PRODUCTS, INC.
90763SE16
In Commercial Distribution

  • M36890763SE161 ()
90763SE16

  • Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
Tube, Breathing, Custom, S=(A=AdultP=Ped.)Tube, w/ExE End Fittings, L" Long. See LotNumber for Custom Hose Info
ANESTHESIA ASSOCIATES, INC.
CTS-E-E-L
In Commercial Distribution

  • B005CTSEEL0 ()
CTS-E-E-L

  • Low-pressure tubing connector, reusable
Castroviejo Caliper, Straight shaft, 0-20mm measuring scale visable from both sides, Fine threaded control screw for maintaining consistent control, Stainless
Diamatrix
M70S
In Commercial Distribution

  • 00813059016003 ()
M70S

  • Ocular hook/spatula/manipulator, reusable
MRSA SCREEN PLATE (Mueller Hinton with 4% NaCl and Oxacillin 6mcg/ml). For the detection of Methicillin Resistant Staphylococcus aureus.
HARDY DIAGNOSTICS
G47
In Commercial Distribution

  • 00816576020126 ()
  • 00816576021284 ()
G47

  • MRSA agar culture medium IVD, selective antimicrobial
5MM DIA., 45CM REUSABLE MONOPOLAR BULLET SUCTION ELECTRODE WITH PROTECTOR SLEEVE FOR USE WITH COMED CORE DISPOSABLE SUCTION/IRRIGATION HANDLE
ELMED INCORPORATED
52845-446
In Commercial Distribution

  • 00842180111950 ()
52845-446

  • Laparoscope system, reusable
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