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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BB Blade with Teeth (Titanium) 22.5mm x 34mm
Modern Surgical Instruments LLC
769-50
In Commercial Distribution

  • 00810130200115 ()


  • Surgical retractor/retraction system blade, reusable
BB, Str, 45L Cv at Hndl w/FlushPort
ARTHREX, INC.
AR-11887F
In Commercial Distribution

  • 00888867274501 ()
AR-11887F

  • Suturing unit, reusable
BB, Str, 45R Cv at Hndl w/FlushPort
ARTHREX, INC.
AR-11886F
In Commercial Distribution

  • 00888867274495 ()
AR-11886F

  • Suturing unit, reusable
S/T 40M LATCH BB C/A HEAD
DARBY DENTAL SUPPLY, LLC
9523552
In Commercial Distribution

  • 00889813044087 ()
9523552

  • Dental surgical power tool motorized handpiece/set, pneumatic
BB*SIE-ART-ZEE-SG-3, 3" ARTISZEE, OR MATTRESS, 2 PIECE
CASCO MANUFACTURING SOLUTIONS, INC.
92479
In Commercial Distribution

  • 00815073027775 ()
92479

  • Operating table mattress, basic
BB Teeth Blade 22mm Wide x 70mm Long
Surgical Direct, Inc.
SD46020T
In Commercial Distribution

  • B382SD46020T0 ()
SD46020T

  • Self-retaining surgical retractor, reusable
VALIDATE CM3 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated and manual instrument systems for the following analytes: homocysteine (HCY) and lipoprotein (a) (LP(a)). Each test kit consists of one bottle each of Levels 1 through 5. Each bottle contains 3.0 milliliters. There exists a linear relationship among Levels 1 through 5.
Lgc Clinical Diagnostics, Inc.
409ro
In Commercial Distribution

  • 00850011135204 ()

  • 2 tests
409ro

  • Multiple cardiac marker IVD, control
  • Homocysteine IVD, control
Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB in Human Heparinized Whole Blood, Plasma, or Serum.
International Point of Care Incorporated
CS3002
Not in Commercial Distribution

  • B103A25CS30021 ()
  • B103CS30020 ()
CS3002

  • Multiple cardiac marker IVD, kit, rapid ICT, clinical
Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB in Human Heparinized Whole Blood, Plasma, or Serum.
International Point of Care Incorporated
CS3002
Not in Commercial Distribution

  • B103A20CS30021 ()
  • B103CS30020 ()
CS3002

  • Multiple cardiac marker IVD, kit, rapid ICT, clinical
Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB in Human Heparinized Whole Blood, Plasma, or Serum.
International Point of Care Incorporated
CS3002
Not in Commercial Distribution

  • B103A10CS30021 ()
  • B103CS30020 ()
CS3002

  • Multiple cardiac marker IVD, kit, rapid ICT, clinical
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