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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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The product is intended to be used as a second Calibrator in a two-point calibration. Calibrator B is aspirated from a sample cup at position 18 on the analyser ASP tray at least once every 8 hours depending on the laboratories schedule.
RANDOX LABORATORIES LIMITED
RX3949
In Commercial Distribution

  • 05055273205954 ()
RX3949

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
ComPel MLR Surgical Gown, 2-Ply Front, Circumferentially Offset Sleeves, Aqua Compel MLR Outer Sleeves and White Compel MLR with Negastat Inner Sleeves, 1-Ply Aqua MLR Comfort Panel Backs, Snap Closures at Neck, Tie Closures at Waist, Barcode, Overcast Safety Stitch Body Size Large
STANDARD TEXTILE CO., INC.
75674395
In Commercial Distribution

  • 00634916709674 ()
  • 10634916709671 ()
75674395

  • Surgical gown, reusable
No Description
W.H. Holden, Inc.
10-6154-1D45
In Commercial Distribution

  • D9281061541D450 ()


  • Dental suction system cannula, reusable
No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
1292.E04
In Commercial Distribution

  • 08717872017150 ()
1292.E04

  • Epiretinal/inner limiting membrane scraper, reusable
Tidal Volume Range(150-1500mL) Media(Foam), Dead Space(34mL), Breathing Resistance(2.8cm H2O at 60 L/min), Weight(15g), Adult
Dynarex Corporation
30203
In Commercial Distribution

  • 00840117305441 ()
  • 00840117305434 ()


  • Heat/moisture exchanger/microbial medical gas filter
Pre-op Toric Reference Marker, Half Circle With 3 Points At 0, 90 and 180 Degrees On A Round Knurled Handle
Surgical Direct, Inc.
S34556.300
In Commercial Distribution

  • B382S345563000 ()
S34556.300

  • Intraocular retractor, reusable
o'gawa tying forceps, smooth, 0.5 mm platform, 0.3 mm gap at heel of platform, 4 1/2" (11.0 cm), straight
NOVO SURGICAL, INC.
OP7127-16
In Commercial Distribution

  • 00842331183775 ()
OP7127-16

  • Open-surgery biopsy forceps, reusable
ZEITEL STYLE ORAL-TRACHEAL VOCAL CORD INJECTION NEEDLE. ANGLED UP 25GA. NEEDLE, 20CM WORKING LENGTH, 3.5MM REDUCED TO 1.2MM AT TIP.
ELMED INCORPORATED
40-0613
In Commercial Distribution

  • 00842180149571 ()
40-0613

  • Mouth gag, adjustable, reusable
Extra Deep Cobra Retractor, Cross Hatched Tip, 12.75” Overall Length, 6.75” Handle Length, Blade Width at the widest is 33mm
ELMED INCORPORATED
23-6134
In Commercial Distribution

  • 00842180148666 ()
23-6134

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Mueller-type Femoral Neck Elevator, 13.5” overall length, 6.5” handle length, 25mm blade width at widest. Autoclavable Medical Grade Stainless Steel.
ELMED INCORPORATED
23-3415
In Commercial Distribution

  • 00842180148482 ()
23-3415

  • Orthopaedic surgical procedure kit, non-medicated, reusable
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