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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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Autoscaler® - 00859191006021

25K Build In Ultrasonic Scaler 120 VAC
SOUTH EAST INSTRUMENTS LLC
AW25BI
In Commercial Distribution

  • 00859191006021 ()


  • Ultrasonic dental scaling/debridement system

Plenity™ - 00860517002603

Super-absorbent hydrogel to aid in weight management.
GELESIS, INC.
MC0451
In Commercial Distribution

  • 00860517002627 ()
  • 00860517002603 ()


  • Ingested gastric satiety device

Case Medical, Inc - 00653159000485

BRACKET SMALL BUMPER 1.7x0.4 in. (10/PK)
Case Medical Inc.
BMS01
In Commercial Distribution

  • 00653159000485 ()
BMS01

  • Instrument tray, reusable

SIGNIA - 05714880141894

KIT STYLETTO SD DAX IN BLK SLV
Ws Audiology Usa, Inc.
KIT Styletto sDemo DAX
In Commercial Distribution

  • 05714880141894 ()
21003784

  • Air-conduction hearing aid, receiver-in-canal

ClearChem Diagnostics Inc. Protein, Total - 00852169008249

In Vitro Diagnostics testing kit R1:4X60mL
CLEARCHEM DIAGNOSTICS INC.
TPR1310
In Commercial Distribution

  • 00852169008249 ()

  • Total Volume: 240 Milliliter
TPR1310

  • Total protein IVD, reagent

ClearChem Diagnostics Inc. Glucose - 00852169008140

In Vitro Diagnostics testing kit R1:4X60mL
CLEARCHEM DIAGNOSTICS INC.
GLU1140
In Commercial Distribution

  • 00852169008140 ()

  • Total Volume: 240 Milliliter
GLU1140

  • Glucose IVD, reagent

ClearChem Diagnostics Inc. Calcium - 00852169008119

In Vitro Diagnostics testing kit R1:4X60mL
CLEARCHEM DIAGNOSTICS INC.
CAL1080
In Commercial Distribution

  • 00852169008119 ()

  • Total Volume: 240 Milliliter
CAL1080

  • Calcium (Ca2+) IVD, reagent

ClearChem Diagnostics Inc. Carbon Dioxide (CO2) - 00852169008072

In Vitro Diagnostics testing kit R1:6X30mL
CLEARCHEM DIAGNOSTICS INC.
CAR1090
In Commercial Distribution

  • 00852169008072 ()

  • Total Volume: 180 Milliliter
CAR1090

  • Carbon dioxide (CO2) IVD, reagent

ClearChem Diagnostics Inc. Amylase - 00852169008041

In Vitro Diagnostics testing kit R1:3X60mL
CLEARCHEM DIAGNOSTICS INC.
AMY1030
In Commercial Distribution

  • 00852169008041 ()

  • Total Volume: 180 Milliliter
AMY1030

  • Amylase isoenzyme IVD, reagent

Valence Robotic Navigation System - 00190376661629

Allen Flex Frame Accessory Rail, 6.0 in
ALPHATEC SPINE, INC.
A-71501
In Commercial Distribution

  • 00190376661629 ()


  • Neurological stereotactic surgery system
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