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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 one device that has DI number included 100 strips
DFI CO.,LTD
30C4
Not in Commercial Distribution

  • 08806141302209 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Chang Hydrodissection Cannula 27 Gauge Flat Tip Angled 90° with beveled opening Long Tip Length 3.0mm
Med Saver, Inc.
11-8-6577
In Commercial Distribution

  • 00194613097455 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Chang Nucleus Hydrodissector cannula 27 gauge 1.5mm flat standard tip angled 90 degree with beveled opening
Medetz Surgical Instruments LLC
12-64353
In Commercial Distribution

  • G22312643530 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials
BECTON, DICKINSON AND COMPANY
442021
In Commercial Distribution

  • 30382904420216 ()
  • 00382904420215 ()

  • Total Volume: 40 Milliliter
442021

  • Culture medium antimicrobial supplement IVD
Goldstein Crown Remover, 90
HU-FRIEDY MFG. CO., LLC
GCR90
In Commercial Distribution

  • 10889950013172 ()
GCR90

  • Dental elevator, tooth/root
Christensen Crown Remover, 90
HU-FRIEDY MFG. CO., LLC
CRCH2
In Commercial Distribution

  • 10889950006983 ()
CRCH2

  • Dental elevator, tooth/root
Steiglitz Root Forceps - 90
HU-FRIEDY MFG. CO., LLC
RF90
In Commercial Distribution

  • 10889950022228 ()
RF90

  • Tooth extraction forceps
PWR Air 90° Handpiece
HU-FRIEDY MFG. CO., LLC
APHP90
In Commercial Distribution

  • 10889950142735 ()


  • Dental abrasive air jet system handpiece
Hex 2.3 / L=90
Megagen Implant Co. Ltd
ARMIT90
In Commercial Distribution

  • 08809931186027 ()
ARMIT90

  • Surgical screwdriver, reusable
Octa 2.1 / L=90
Megagen Implant Co. Ltd
BDMITN90
In Commercial Distribution

  • 08809931185983 ()
BDMITN90

  • Surgical screwdriver, reusable
Hex 2.5 / L=90
Megagen Implant Co. Ltd
AOMIT90
In Commercial Distribution

  • 08809931185969 ()
AOMIT90

  • Surgical screwdriver, reusable
Octa 2.5 / L=90
Megagen Implant Co. Ltd
BDMITR90
In Commercial Distribution

  • 08809931186003 ()
BDMITR90

  • Surgical screwdriver, reusable
gate, length 90 mm
Ulrich GmbH & Co. KG
CS 3603-090
Not in Commercial Distribution

  • 04052536019113 ()
CS 3603-090

  • Spinal fixation plate, non-bioabsorbable
MONTHLY MAINTENANCE KIT 6-PACK, CM130 (Model Number 9756600; Primary DI Number 00851575007365) that contains 6 individual MONTHLY MAINTENANCE KITs (Model Number 9717300; Primary DI Number 00851575007242)
HACH COMPANY
9756600
In Commercial Distribution

  • 00851575007365 ()
9756600

  • Haemodialysis system chlorine monitor
The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the qualitative detection of two point mutations in exon 7 [p.R248C (c.742C>T), p.S249C (c.746C>G)], two point mutations in exon 10 [p.G370C (c.1108G>T) and p.Y373C (c.1118A>G)] and two fusions (FGFR3-TACC3v1 and FGFR3-TACC3v3) in the fibroblast growth factor receptor 3 (FGFR3) gene in RNA samples derived from formalin-fixed paraffin-embedded (FFPE) urothelial tumor tissue. The test is indicated for use as an aid in identifying patients with cases of urothelial cancer (UC) which harbor these alterations and are therefore eligible for treatment with BALVERSA™ (erdafitinib). Specimens are processed using the RNeasy DSP FFPE Kit for manual sample preparation followed by reverse transcription and then automated amplification and detection on the Rotor-Gene Q MDx (US) instrument.
QIAGEN GmbH
2
In Commercial Distribution

  • 04053228043560 ()
874721

  • Fibroblast growth factor receptor (FGFR) gene mutation IVD, kit, nucleic acid technique (NAT)
QuickGraft Pre-Sutured Tendon
Musculoskeletal Transplant Foundation, Inc.
430PST
In Commercial Distribution

  • W41844300PSTT165 ()
430PST

  • Tendon graft
Unimom accessory(27mm shield set)
UNIMOM CO.
Breast Shield Kit SE (Large)
In Commercial Distribution

  • 08809224872088 ()

  • Lumen/Inner Diameter: 27 Millimeter


  • Breast pump support kit, reusable
This is a funnel shaped accessory, which come in contact with breast to express milk.
UNIMOM CO.
Breast Shield (27mm)
In Commercial Distribution

  • 08809224871364 ()

  • Lumen/Inner Diameter: 27 Millimeter


  • Breast pump support kit, reusable
Laparoscopic Electrode with a 3/32" pin connector, J-HOOK 5 mm x 27 cm
Conmed Corporation
60-5164-002
In Commercial Distribution

  • 20653405009792 ()
  • 30653405009799 ()
  • 00653405009798 ()

  • Length: 27 Centimeter
  • Outer Diameter: 5 Millimeter
60-5164-002

  • Endoscopic electrosurgical electrode, monopolar, single-use
Laparoscopic Electrode with a 3/32" pin connector, L-HOOK 5 mm x 27 cm
Conmed Corporation
60-5163-002
In Commercial Distribution

  • 20653405009778 ()
  • 30653405009775 ()
  • 00653405009774 ()

  • Length: 27 Centimeter
  • Outer Diameter: 5 Millimeter
60-5163-002

  • Endoscopic electrosurgical electrode, monopolar, single-use
Laparoscopic Electrode with a 3/32" pin connector, L-HOOK 5 mm x 27 cm
Conmed Corporation
60-5162-001
In Commercial Distribution

  • 20653405009747 ()
  • 30653405009744 ()
  • 00653405009743 ()

  • Length: 32 Centimeter
  • Outer Diameter: 5 Millimeter
60-5162-001

  • Endoscopic electrosurgical electrode, monopolar, single-use
Laparoscopic Electrode with a 3/32" pin connector, SPATULA 5 mm x 27 mm
Conmed Corporation
60-5159-002
In Commercial Distribution

  • 20653405009662 ()
  • 30653405009669 ()
  • 00653405009668 ()

  • Length: 27 Centimeter
  • Outer Diameter: 5 Millimeter
60-5159-002

  • Endoscopic electrosurgical electrode, monopolar, single-use
TiAl6V4 ELI non-sterile
Merete GmbH
27
Not in Commercial Distribution

  • 04048266076373 ()

  • Length: 27 Millimeter
FH03027

  • Orthopaedic fixation plate, non-bioabsorbable
The 32Ch AIR Open Coil Suite is comprised of MRI receive-only phased array RF coils designed for clinically acceptable signal-to-noise ratio (SNR) and uniform coverage of the Head, Neck and Brachial Plexus anatomy for use with GE Healthcare Magnetic Resonance Imaging (MRI) scanners. The 32Ch AIR Open Coil Suite consists of the following arrays available in 1.5T and 3.0T field strengths: • AIR Open Head Neck Posterior 9ch • AIR Open Neck Chest Anterior 7ch • AIR Open Head Anterior 16ch The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Head, Neck and Brachial Plexus anatomy while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. The received signals are amplified before being transferred to the MRI scanner through the coil’s system cable. The amplified signals are processed by the MRI scanner into tomographic images of the Head, Neck and Brachial Plexus anatomy by the MRI scanner. Images are typically generated as axial, sagittal, coronal oblique slices. There are no accessories associated with the 32Ch AIR Open Coil Suite. Depending on the region of interest, the coils may be used in combination with the CIVCO RT Universal Couchtop™ MRI Overlay for compatible MR table(s) and associated patient immobilization devices (e.g., thermoplastic mask, straps provided with the MRI scanner).
NEOCOIL, LLC
27
In Commercial Distribution

  • 00850028932278 ()
NC139202

  • MRI system coil, radio-frequency
No Description
Roland Consult Stasche & Finger GmbH
27
In Commercial Distribution

  • 04260157780279 ()


  • Electroretinograph
  • Electrooculograph
No Description
Directa AB
27
In Commercial Distribution

  • 17310236092275 ()
609227

  • Preformed dental crown, temporary
The Home Access Health Corporation Hepatitis C Check Test System is intended for use by persons to determine if antibodies to HCV (Hepatitis C) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing.
Home Access Health Corporation
27
In Commercial Distribution

  • M769HCV271 ()


  • Capillary blood collection set, home-use
Micro Raspatory, 2 mm, length 27 cm
Karl Storz GmbH & Co. KG
28164ER
In Commercial Distribution

  • 04048551104408 ()
28164ER

  • Open-surgery dissector
Micro Raspatory, 2 mm, length 27 cm
Karl Storz GmbH & Co. KG
28164EL
In Commercial Distribution

  • 04048551104354 ()
28164EL

  • Open-surgery dissector
MOSS VRS Ti Locking Cap Star 27
Biedermann Motech GmbH & Co. KG
108-004-0002
In Commercial Distribution

  • 04250869634755 ()
108-004-0002

  • Spinal bone set screw
MedDrain 19 Fr Closed Wound Drain - Round 88 Eyes
ARMM INC.
222019
In Commercial Distribution

  • 10850082007711 ()
  • 00850082007714 ()


  • Closed-wound drain, non-bioabsorbable
MedDrain 15 Fr Closed Wound Drain - Round 88 Eyes
ARMM INC.
222015
In Commercial Distribution

  • 10850082007704 ()
  • 00850082007707 ()


  • Closed-wound drain, non-bioabsorbable
MedDrain 10 Fr Closed Wound Drain - Round 88 Eyes
ARMM INC.
222010
In Commercial Distribution

  • 10850082007674 ()
  • 00850082007677 ()


  • Closed-wound drain, non-bioabsorbable
MedDrain 7 Fr Closed Wound Drain - Round 88 Eyes
ARMM INC.
222070
In Commercial Distribution

  • 10850082007667 ()
  • 00850082007660 ()


  • Closed-wound drain, non-bioabsorbable
7.0 x 88 mm Headless, Cannulated, Short Thread Screw
Paragon 28, Inc.
P20-570-088S
In Commercial Distribution

  • 00889795008916 ()

  • 7.0 x 88 mm Headless, Cannulated, Short Thread Screw
  • Outer Diameter: 7 Millimeter
P20-570-088S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
7.0 x 88 mm Headless, Cannulated, Medium Thread Screw
Paragon 28, Inc.
P20-570-088M
In Commercial Distribution

  • 00889795008909 ()

  • 7.0 x 88 mm Headless, Cannulated, Medium Thread Screw
  • Outer Diameter: 7 Millimeter
P20-570-088M

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
7.0 x 88 mm Headless, Cannulated, Long Thread Screw
Paragon 28, Inc.
P20-570-088L
In Commercial Distribution

  • 00889795008893 ()

  • Outer Diameter: 7 Millimeter
  • 7.0 x 88 mm Headless, Cannulated, Long Thread Screw
P20-570-088L

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
7.0 x 88 mm Headed, Cannulated, Short Thread Screw
Paragon 28, Inc.
P20-170-088S
In Commercial Distribution

  • 00889795005786 ()

  • 7.0 x 88 mm Headed, Cannulated, Short Thread Screw
  • Outer Diameter: 7 Millimeter
P20-170-088S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
7.0 x 88 mm Headed, Cannulated, Medium Thread Screw
Paragon 28, Inc.
P20-170-088M
In Commercial Distribution

  • 00889795005779 ()

  • 7.0 x 88 mm Headed, Cannulated, Medium Thread Screw
  • Outer Diameter: 7 Millimeter
P20-170-088M

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
7.0 x 88 mm Headed, Cannulated, Long Thread Screw
Paragon 28, Inc.
P20-170-088L
In Commercial Distribution

  • 00889795005762 ()

  • 7.0 x 88 mm Headed, Cannulated, Long Thread Screw
  • Outer Diameter: 7 Millimeter
P20-170-088L

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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