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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SUR-FIT Natura® Urostomy Pouch With Accuseal® Tap, Trans. Standard, W/1-Sided Comfort Panel, 2 3/4"
CONVATEC, PURCHASING DEPARTMENT
401546
In Commercial Distribution

  • 10768455103628 ()
  • 00768455103621 ()
  • 00768455182800 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Urostomy Pouch With Accuseal® Tap, Trans. Standard, W/1-Sided Comfort Panel, 2 1/4"
CONVATEC, PURCHASING DEPARTMENT
401545
In Commercial Distribution

  • 10768455103611 ()
  • 00768455103614 ()
  • 00768455182794 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Urostomy Pouch With Accuseal® Tap, Trans. Standard, W/1-Sided Comfort Panel, 1 3/4"
CONVATEC, PURCHASING DEPARTMENT
401544
In Commercial Distribution

  • 10768455103604 ()
  • 00768455103607 ()
  • 00768455182787 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Urostomy Pouch With Accuseal® Tap, Trans. Standard, W/1-Sided Comfort Panel, 1 1/2"
CONVATEC, PURCHASING DEPARTMENT
401543
In Commercial Distribution

  • 10768455103598 ()
  • 00768455103591 ()
  • 00768455182770 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Urostomy Pouch With Accuseal® Tap, Trans. Standard, W/1-Sided Comfort Panel, 1 1/4"
CONVATEC, PURCHASING DEPARTMENT
401542
In Commercial Distribution

  • 10768455103581 ()
  • 00768455103584 ()
  • 00768455182763 ()


  • Multiple-piece urostomy bag, open-ended
Esteem®+ Moldable One-Piece Drainable Pouch W/ Inviclose, Filter, Stomahesive, Two-Sided Window Comfort Panel 12" Opaque, (40/50M
CONVATEC, PURCHASING DEPARTMENT
413523
In Commercial Distribution

  • 10768455130259 ()
  • 00768455130252 ()
  • 00768455187836 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Moldable One-Piece Drainable Pouch W/ Inviclose, Filter, Stomahesive, Two-Sided Window Comfort Panel 12" Opaque, (30/40M
CONVATEC, PURCHASING DEPARTMENT
413522
In Commercial Distribution

  • 10768455130242 ()
  • 00768455130245 ()
  • 00768455187829 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Moldable One-Piece Drainable Pouch W/ Inviclose, Filter, Stomahesive, Two-Sided Window Comfort Panel 12" Opaque, (20/30M
CONVATEC, PURCHASING DEPARTMENT
413521
In Commercial Distribution

  • 10768455130235 ()
  • 00768455130238 ()
  • 00768455187812 ()


  • One-piece intestinal ostomy bag, open-ended
No Description
SRS Medical Systems, Inc.
900-024-2
In Commercial Distribution

  • 00890477000104 ()


  • Biomechanical function analysis system, motion-tracking
  • Electronic goniometer/kinesiology sensor
  • Biofeedback system application software
  • Electromyograph
Audyx is an online audiology platform for patients care. It runs on a computing device connected to the Internet as well as to an electro-acoustic system to produce controlled signals to perform audiometric evaluation and to assist in the diagnosis of otological disorders
KOALYS TECHNOLOGIES LTD
2.X
In Commercial Distribution

  • 07290017820019 ()
N/A

  • Tone audiometer
The BioCode MDx 3000 is an automated molecular diagnostic system for use with Applied BioCode’s Barcoded Magnetic Beads (BMB) assays.
APPLIED BIOCODE, INC.
1
In Commercial Distribution

  • 00851034007004 ()
41-A0051

  • Microplate reader IVD, automated/semi-automated
Definium Tempo System UDI
GE Hualun Medical Systems Co., Ltd
Tempo
In Commercial Distribution

  • 00195278118356 ()
B2401CAB

  • Stationary basic diagnostic x-ray system, digital
Definium Tempo Pro System UDI
GE Hualun Medical Systems Co., Ltd
Tempo Pro
In Commercial Distribution

  • 00195278070265 ()
B2402CAB

  • Stationary basic diagnostic x-ray system, digital
The CR-IR 392 is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 392
In Commercial Distribution

  • 04547410472905 ()


  • Computed radiography digital imaging scanner
The CR-IR 392 is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 392
In Commercial Distribution

  • 04547410472882 ()


  • Computed radiography digital imaging scanner
The CR-IR 392 is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 392
In Commercial Distribution

  • 04547410343816 ()


  • Computed radiography digital imaging scanner
BD MAX™ Enteric Parasite Panel (US/CAN) Contains: 24 Master Mix, 24 Extraction Tubes, 24 1.5 mL Sample Buffer tubes, 25 Septum Caps, 24 Strips Containing, Wash Buffer, Elution Buffer, Neutralization Buffer
Geneohm Sciences Canada Inc
443380
Not in Commercial Distribution

  • 00382904433802 ()
443380

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
KIT PREWARM MAX6
BECTON, DICKINSON AND COMPANY
443159
In Commercial Distribution

  • 00382904431594 ()
443159

  • Test tube heater
The EasyScreen™ Gastrointestinal Parasite PCR Positive Control (PC-PROT-001) is a control material for nucleic acid testing of patient clinical samples. It is designed to provide a positive PCR signal for each of the protozoan targets in the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005). The Positive Control does not require processing and is designed to be added directly to the PCR mastermix when a positive signal in all detection channels is required for quality control purposes. This Positive Control demonstrates that all PCR targets are being detected as expected, and does not provide any results from clinical specimens. This Positive Control is for Investigational in vitro Diagnostic (IVD) Use Only in hospital and pathology laboratories or similar, by trained personnel.
GENETIC SIGNATURES LIMITED
1
In Commercial Distribution

  • 09351179004070 ()
PC-PROT-001

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Discovery XR656 HD System
GE Hualun Medical Systems Co., Ltd
XR656 HD
In Commercial Distribution

  • 00840682138598 ()


  • Stationary basic diagnostic x-ray system, digital
XR656 SYS Cabinet UDI
GE Hualun Medical Systems Co., Ltd
XR656
In Commercial Distribution

  • 00840682115322 ()


  • Stationary basic diagnostic x-ray system, digital
Shiga Toxin Direct Test Cartridge with sample prep device.
GREAT BASIN SCIENTIFIC, INC.
GBSTEC-10
In Commercial Distribution

  • B178GBSTEC102 ()
  • B178GBSTEC100 ()
GBSTEC-10

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) vials of PCR Master Mix and eight (8) vials of dried Assay Control which comprise enough reagents required to perform eight (8) Acuitas AMR Gene Panel assays.
Curetis GmbH
Acuitas AMR Gene Panel Reagent Kit
Not in Commercial Distribution

12002

  • Nucleic acid amplification mastermix kit IVD
Patient Restraint and Safety Strap with Padded Mid Panel. Mid Panel padding is covered in a Visco memory foam, strap is fiber reinforced rubber that is extremely durable and easily cleaned. Features two airplane style buckles to adjust strap length.
David Scott Company
BD800-PAD
In Commercial Distribution

  • 15060797552337 ()

  • Width: 2 Inch
  • Length: 96 Inch
BD800-PAD

  • Medical table restraint anchor
Ten Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo:BAR | BUP | BZO | COC | MET | MTD | OPI | OXY | TCA | THC
MERGERS MARKETING, INC.
PS-DOA-7104
In Commercial Distribution

  • 00850557007348 ()
  • 00850557007355 ()
  • 10850557007352 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Twelve Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BAR | BUP | BZO | COC | MDMA | MET | MOR | MTD | OXY | PCP | THC
MERGERS MARKETING, INC.
PS-DOA-6125
In Commercial Distribution

  • 00850557007300 ()
  • 00850557007317 ()
  • 10850557007314 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Twelve Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo:AMP | BAR | BZO | COC | MDMA | MET | MOR | MTD | OXY | PCP | TCA | THC
MERGERS MARKETING, INC.
PS-DOA-7125
In Commercial Distribution

  • 00850557007249 ()
  • 00850557007256 ()
  • 10850557007253 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MDMA | MET | MTD | OPI | PCP | THC
MERGERS MARKETING, INC.
PS-DOA-3104
In Commercial Distribution

  • 10850557007239 ()
  • 00850557007232 ()
  • 00850557007225 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Twelve Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MDMA | MET | MTD | OPI | OXY | PCP | PPX | THC
MERGERS MARKETING, INC.
PS-DOA-1124
In Commercial Distribution

  • 10850557007093 ()
  • 00850557007096 ()
  • 00850557007089 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Eleven Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BAR| BZO| COC | MDMA | MET | OPI | MTD | PPX | PCP | THC
MERGERS MARKETING, INC.
PS-DOA-1114
In Commercial Distribution

  • 00850557007065 ()
  • 00850557007072 ()
  • 10850557007079 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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