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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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St. Mark's Deep Pelvic Retractor, hollow handle, 7" x 2-1/2" tapers to 3-1/2cm's at tip, with lip
Hayden Medical, Inc.
240-585
In Commercial Distribution

  • 00840319707708 ()
240-585

  • Hand-held surgical retractor, reusable
VOMIT AND URINE WHITE BAG (EMESIS) WITH INNER LEAK PROOF VALVE AND 6" WIDE RIGID OPENING AT THE TOP.
KENTRON HEALTHCARE, INC.
404087
In Commercial Distribution

  • 00810003751201 ()
  • 00810003751195 ()
  • 00810003751188 ()
404087

  • Emesis bag
Integra® Miltex® Iris Tissue Forceps 4", Standard, Straight, 1 x 2 Teeth, 0.8mm wide at Tip, Non-Magnetic
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-787
In Commercial Distribution

  • H834187870 ()
  • 10381780417903 ()
18-787

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
2 7/8 inch Troutman-Barraquer Colibri Corneal Forceps, 0.12mm, 1 X 2 Teeth Set at 45 Degree, Flat Handle
Surgical Direct, Inc.
SD902751100
In Commercial Distribution

  • B382SD9027511000 ()
SD902751100

  • Dressing/utility forceps, scissors-like, reusable
Integra® Jarit® Iris Tissue Forceps 4", Standard, Straight, 1 x 2 Teeth, 0.8mm Wide at Tip, Non-Magnetic
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
X29898
In Commercial Distribution

  • M274X298981 ()
  • 10381780406136 ()
X29898

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
The plusoptiX 16 is a hand held autorefractor and measures refractive data, pupil size, pupil distance and gaze deviation in real time. Both eyes are measured at the same time (binocular) at a distance of one meter (3.3 ft) to the patient eyes.
Plusoptix GmbH
A16
In Commercial Distribution

  • 04260184514113 ()
  • 04260184514120 ()
A16

  • External ocular measurement camera
The plusoptiX 12 is a hand held autorefractor and measures refractive data, pupil size, pupil distance and gaze deviation in real time. Both eyes are measured at the same time (binocular) at a distance of one meter (3.3 ft) to the patient eyes.
Plusoptix GmbH
A12C
In Commercial Distribution

  • 04260184512119 ()
  • 04260184512126 ()
A12C

  • External ocular measurement camera
The plusoptiX 16 is a hand held autorefractor and measures refractive data, pupil size, pupil distance and gaze deviation in real time. Both eyes are measured at the same time (binocular) at a distance of one meter (3.3 ft) to the patient eyes.
Plusoptix GmbH
S16
In Commercial Distribution

  • 04260184514212 ()
  • 04260184514229 ()
S16

  • External ocular measurement camera
The plusoptiX 12 is a hand held autorefractor and measures refractive data, pupil size, pupil distance and gaze deviation in real time. Both eyes are measured at the same time (binocular) at a distance of one meter (3.3 ft) to the patient eyes.
Plusoptix GmbH
S12R
In Commercial Distribution

  • 04260184513215 ()
  • 04260184513222 ()
S12R

  • External ocular measurement camera
The plusoptiX 12 is a hand held autorefractor and measures refractive data, pupil size, pupil distance and gaze deviation in real time. Both eyes are measured at the same time (binocular) at a distance of one meter (3.3 ft) to the patient eyes.
Plusoptix GmbH
A12R
In Commercial Distribution

  • 04260184513116 ()
  • 04260184513123 ()
A12R

  • External ocular measurement camera
The plusoptiX 12 is a hand held autorefractor and measures refractive data, pupil size, pupil distance and gaze deviation in real time. Both eyes are measured at the same time (binocular) at a distance of one meter (3.3 ft) to the patient eyes.
Plusoptix GmbH
S12C
In Commercial Distribution

  • 04260184512218 ()
  • 04260184512225 ()


  • External ocular measurement camera
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
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
No Description
W.H. Holden, Inc.
10-6154-1D45
In Commercial Distribution

  • D9281061541D450 ()


  • Dental suction system cannula, reusable
TrackX adapter that enables physicians to more adequately utilize the INSIGHT BASE-NV/AT DISC PREP SNAP on their surgical instrument.
TrackX Technology, LLC
TrackX AT INSERT-ADAPT - MJF VS
In Commercial Distribution

  • 00857088008820 ()
TX-3-4229

  • Diagnostic x-ray digital imaging system workstation application software
No Description
U&C International Co.,Ltd
W ML AT BL0 30
In Commercial Distribution

  • 08800118630142 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
W ML AT BL2 30
In Commercial Distribution

  • 08800118624219 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
W ML AT BL2 28
In Commercial Distribution

  • 08800118624202 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
W ML AT BL2 25
In Commercial Distribution

  • 08800118624196 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
W ML AT BL2 22
In Commercial Distribution

  • 08800118624189 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
W ML AT BL2 20
In Commercial Distribution

  • 08800118624172 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
W ML AT BL2 18
In Commercial Distribution

  • 08800118624165 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
W ML AT BL2 14
In Commercial Distribution

  • 08800118624141 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
W ML AT BL2 10
In Commercial Distribution

  • 08800118624127 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
W ML AT D4 30
In Commercial Distribution

  • 08800118619000 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
W ML AT D4 28
In Commercial Distribution

  • 08800118618997 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
W ML AT D3 30
In Commercial Distribution

  • 08800118618980 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
W ML AT D3 28
In Commercial Distribution

  • 08800118618973 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
W ML AT D2 30
In Commercial Distribution

  • 08800118618966 ()


  • Dental appliance fabrication material, ceramic
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