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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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CHOLESTEROL (CHOL) - 05055273201130

For the quantitative in vitro determination of Cholesterol in serum and plasma.
RANDOX LABORATORIES LIMITED
CH200
In Commercial Distribution

  • 05055273201130 ()


  • Total cholesterol lipid IVD, kit, spectrophotometry

IDG/Sanzay - 00850053916151

For the in vitro quantitative determination of Triglycerides in serum or plasma.
IDG/SANZAY Corporation
1
In Commercial Distribution

  • 00850053916151 ()

  • Total Volume: 100 Milliliter
  • Total Volume: 120 Milliliter
  • Total Volume: 240 Milliliter
  • Total Volume: 250 Milliliter
  • Total Volume: 480 Milliliter
  • Total Volume: 500 Milliliter
  • Total Volume: 1 Liter
C403

  • Triglyceride IVD, reagent

BlackJack - 00850042446225

8-ft in line male bed to in line bed 37 pin cable
HATCHMED CORPORATION
M8
In Commercial Distribution

  • 00850042446225 ()
M8

  • Electrical-only medical device connection cable, reusable

BlackJack - 00850042446218

8-ft in line female bed to in line bed 37 pin cable
HATCHMED CORPORATION
F8
In Commercial Distribution

  • 00850042446218 ()
F8

  • Electrical-only medical device connection cable, reusable

WaterPAP Pro - 00709078013201

WaterPAP Pro (10 devices in one box. 10 boxes in one case)
WESTMED, INC.
WP-7800
In Commercial Distribution

  • 00709078013201 ()
  • 10709078013208 ()


  • PEEP valve, single-use

Sterrad - 10705037043002

Instrument Tray Mats165 mm X 64 mm (6.5 in. x 2.5 in.)
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
99205
In Commercial Distribution

  • 20705037043009 ()
  • 10705037043002 ()
99205

  • Instrument tray, reusable

Tatum Surgical-Integrity Implant 8.0x20, Bone Level - 00083208498008

Integrity Dental Implant 8.0mm in diameter and 20mm in length, bone level
Suncoast Dental, Inc
ITI-B 8.0x20
Not in Commercial Distribution

  • 00083208498008 ()

  • Height: 20 Millimeter
  • Outer Diameter: 8.0 Millimeter
ITI-B 8.0x20

  • Screw endosteal dental implant, two-piece

Triglyceride - 00811727013668

For the in vitro quantitative determination of Triglycerides in serum or plasma.
POINTE SCIENTIFIC, INC.
12-T7532-160
In Commercial Distribution

  • 00811727013668 ()
12-T7532-160

  • Triglyceride IVD, reagent

Lipase - 00811727013613

For the in vitro quantitative kinetic determination of Pancreatic Lipase in serum.
POINTE SCIENTIFIC, INC.
12-L7503-40
In Commercial Distribution

  • 00811727013613 ()
12-L7503-40

  • Lipase IVD, kit, spectrophotometry

Sklar - 10649111385865

CENSITRAC READY RUMEL THOR FCP 2-3/8 IN ,9 IN FL CVD
SKLAR CORPORATION
55-3127C
In Commercial Distribution

  • 10649111385865 ()


  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
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