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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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Gibson Healthcare - D74440719341

BENCO C7 3-0 PL GUT 27"/70CM
BENCO DENTAL SUPPLY CO.
4071-934
In Commercial Distribution

  • D74440719341 ()
  • D74440719340 ()

  • 3-0 USP
4071-934

  • Catgut suture, plain

Gibson Healthcare - D74440718631

BENCO C6 3-0 CH GUT 27"/70CM
BENCO DENTAL SUPPLY CO.
4071-863
In Commercial Distribution

  • D74440718631 ()
  • D74440718630 ()

  • 3-0 USP
4071-863

  • Catgut suture, chromic

Gibson Healthcare - D74440719251

BENCO C6 4-0 PL GUT 27"/70CM
BENCO DENTAL SUPPLY CO.
4071-925
In Commercial Distribution

  • D74440719251 ()
  • D74440719250 ()

  • 4-0 USP
4071-925

  • Catgut suture, plain

UNIVERSAL PLUS - 30653405010603

UNIVERSAL PLUS LAPAROSCOPIC ELECTRODE WITH SUCTION/IRRIGATION, L-HOOK 5 MM X 27 CM
Conmed Corporation
60-5272-127
In Commercial Distribution

  • 20653405010606 ()
  • 30653405010603 ()
  • 00653405010602 ()

  • Length: 27 Centimeter
  • Outer Diameter: 5 Millimeter
60-5272-127

  • Endoscopic electrosurgical electrode, monopolar, single-use

UNIVERSAL PLUS - 30653405010573

UNIVERSAL PLUS LAPAROSCOPIC ELECTRODE WITH SUCTION/IRRIGATION, SPATULA 5 MM X 27 CM
Conmed Corporation
60-5272-027
In Commercial Distribution

  • 20653405010576 ()
  • 30653405010573 ()
  • 00653405010572 ()

  • Length: 27 Centimeter
  • Outer Diameter: 5 Millimeter
60-5272-027

  • Endoscopic electrosurgical electrode, monopolar, single-use

MS X-RAY GRID - 04589744212284

237x290.5mm, 15:1, 100cm, 80L/cm, Material Number: 11514199
MITAYA MANUFACTURING CO., LTD.
GMS4K15100080S0001
In Commercial Distribution

  • 04589744212284 ()


  • Stationary x-ray grid

UbiqVue Multiparameter - B353UB25501

2A Wearable Biosensor
Lifesignals, Inc.
UB2550
In Commercial Distribution

  • B353UB25502 ()
  • B353UB25501 ()
  • B353UB25503 ()


  • Wearable multiple physiological parameter recorder, single-use

UbiqVue Multiparameter - B353UB15501

1AX Wearable Biosensor
Lifesignals, Inc.
UB1550
In Commercial Distribution

  • B353UB15501 ()
  • B353UB15502 ()
  • B353UB15503 ()


  • Wearable multiple physiological parameter recorder, single-use

MonitorMe - B353MM12501

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
MM1250
Not in Commercial Distribution

  • B353MM12501 ()
  • B353MM12502 ()
  • B353MM12503 ()


  • Electrocardiography telemetric monitoring system

MAWI - B353MA12511

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
MA1251
Not in Commercial Distribution

  • B353MA12512 ()
  • B353MA12511 ()
  • B353MA12513 ()
MA1251_US

  • Electrocardiography telemetric monitoring system

LifeSignals - B353LP12531

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
LP1253
In Commercial Distribution

  • B353LP12532 ()
  • B353LP12531 ()
  • B353LP12533 ()
LP1253_US

  • Electrocardiography telemetric monitoring system

LifeSignals - B353LP12511

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
LP1251
In Commercial Distribution

  • B353LP12511 ()
LP1251_US

  • Electrocardiographic ambulatory recorder

LifeSignals - B353LP12501

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
LP1250
Not in Commercial Distribution

  • B353LP12502 ()
  • B353LP12501 ()
  • B353LP12503 ()


  • Electrocardiographic ambulatory recorder

CorVitals - B353CV12531

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
CV1253
In Commercial Distribution

  • B353CV12532 ()
  • B353CV12531 ()
  • B353CV12533 ()
CV1253_US

  • Electrocardiography telemetric monitoring system

CORVITALS - B353CV12451

Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
CV1245
Not in Commercial Distribution

  • B353CV12452 ()
  • B353CV12451 ()
  • B353CV12453 ()


  • Electrocardiography telemetric monitoring system

Advance Biometrix - B353AB12571

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1257
Not in Commercial Distribution

  • B353AB12572 ()
  • B353AB12571 ()
  • B353AB12573 ()
AB1257_US

  • Electrocardiographic ambulatory recorder

Advance Biometrix - B353AB12511

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1251
Not in Commercial Distribution

  • B353AB12512 ()
  • B353AB12511 ()
  • B353AB12513 ()
AB1251_US

  • Electrocardiographic ambulatory recorder

CYBOW 10 - 08806141302070

The one device that has DI number included 100 strips
DFI CO.,LTD
0004
In Commercial Distribution

  • 08806141302070 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

QTEST™ 11 - 08806141301479

The one device that has DI number included 100 strips.
DFI CO.,LTD
0994
In Commercial Distribution



  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Just Fitter 10 Parameter Test Strips - 08806141302209

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

CYBOW P - 08806141302094

The one device that has DI number included 100 strips
DFI CO.,LTD
0144
In Commercial Distribution

  • 08806141302094 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

HACH - 00851575007365

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

Unimom - 08809224872088

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

Unimom - 08809224871364

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

Medetz Surgical Instruments - G22312643530

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

MSI Precision Specialty Instruments - 00194613097455

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

QuickGraft - W41844300PSTT165

QuickGraft Pre-Sutured Tendon
Musculoskeletal Transplant Foundation, Inc.
430PST
In Commercial Distribution

  • W41844300PSTT165 ()
430PST

  • Tendon graft

therascreen® FGFR RGQ RT-PCR Kit - 04053228043560

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)

BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials - 00382904420215

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

HU-FRIEDY - 10889950022228

Steiglitz Root Forceps - 90
HU-FRIEDY MFG. CO., LLC
RF90
In Commercial Distribution

  • 10889950022228 ()
RF90

  • Tooth extraction forceps
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