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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 ZEUS ELISA Thyroglobulin (Tg) IgG Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibody to thyroglobulin in human serum. The test system is intended to be used as an aid in the diagnosis of thyroid diseases. This test is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
2Z5061G
In Commercial Distribution

  • 00845533001175 ()
2Z5061G

  • Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
TG-300
In Commercial Distribution

  • 00816870020198 ()

  • Width: 2 Inch
TG-300

  • Thyroglobulin antibody IVD, control
No Description
Berman Instruments LLC
CKP13
Not in Commercial Distribution

  • 00810060722206 ()


  • Periodontal hoe
Pericardiocentesis Kit
BOSTON SCIENTIFIC CORPORATION
M00443150
In Commercial Distribution

  • 08714729333258 ()
  • 08714729744887 ()

  • 2.8 mm Diameter
  • 50 cm Effective Length
  • 8.3 F Diameter


  • Pericardiocentesis needle, single-use
Pericardiocentesis Kit
BOSTON SCIENTIFIC CORPORATION
M00443050
In Commercial Distribution

  • 08714729333234 ()
  • 08714729744856 ()

  • 2.8 mm Diameter
  • 8.3 F Diameter
  • 41 cm Effective Length


  • Pericardiocentesis needle, single-use
Pericardial Drainage Collection Bag
BOSTON SCIENTIFIC CORPORATION
M0044000
In Commercial Distribution

  • 08714729268086 ()
  • 08714729268079 ()

  • 1000 mL Volume


  • Pericardiocentesis needle, single-use
No Description
EPIEP, INC.
0399-13950
In Commercial Distribution

  • B3000399139500 ()


  • Pericardiocentesis needle, single-use
SUCTION 12006 ASPIRATING NEEDLE 16GA 20P
MEDTRONIC, INC.
12006
In Commercial Distribution

  • 20613994794578 ()
  • 00613994794574 ()

  • Needle Gauge: 16.0 Gauge


  • Pericardiocentesis needle, single-use
Tinted Glow Powder
JBC and Company
10
In Commercial Distribution

  • D85110 ()
10

  • Dental appliance fabrication material, resin
No Description
MANI, INC.
10
In Commercial Distribution

  • 04546951500016 ()
  • 14546951500013 ()
10

  • Nylon suture, non-bioabsorbable, monofilament
Kids Size Silicone Earplugs - 6 pair box - Orange
McKeon Products, Inc.
Kids Size Soft Moldable Silicone Putty Earplugs
In Commercial Distribution

  • 10033732000106 ()
  • 00033732000109 ()
10

  • Earplugs, reusable
No Description
DOLABANY EYEWEAR
AT8399 C2
In Commercial Distribution

  • 00818399254184 ()
10

  • Tinted non-prescription spectacles
NRHZ: A sterile device designed to be securely attached to the septum end of a vial to create a channel, by spiking through the vial's sealed stopper, to allow access to the contents of the vial. This device is intended to reduce risk of unwanted exposure to the vial's contents (e.g., liquid medication) by providing a sterile pathway between the vial and a recipient receptacle/device for subsequent delivery to a patient. It typically consists of polyvinyl chloride (PVC) screw cap with an internal spike and an external connector. This is a single-use device.
DRAGON HEART MEDICAL, INC.
R001
Not in Commercial Distribution

  • B346R0011 ()
  • B346R00129 ()
10

  • Medical air terminal unit
3M™ ESPE™ Adult Anterior Polycarbonate Replacement Crown, Upper Right Centrals, Size 10, 10
3M COMPANY
10
In Commercial Distribution

  • 50605861025312 ()
  • 30605861025318 ()
  • 00605861022392 ()
10

  • Preformed dental crown, temporary
4.8mm Diameter, 6.5mm Platform TG Implant Length 14mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/6TG14S2
In Commercial Distribution

  • 00842448114457 ()


  • Dental implant system
4.8mm Diameter, 6.5mm Platform TG Implant Length 12mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/6TG12S2
In Commercial Distribution

  • 00842448114433 ()


  • Dental implant system
4.8mm Diameter, 6.5mm Platform TG Implant Length 10mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/6TG10S2
In Commercial Distribution

  • 00842448114419 ()


  • Dental implant system
4.8mm Diameter, 6.5mm Platform TG Implant Length 14mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/6TG14R1
In Commercial Distribution

  • 00842448114365 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 14mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/4TG14S2
In Commercial Distribution

  • 00842448114310 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 12mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/4TG12S2
In Commercial Distribution

  • 00842448114297 ()


  • Dental implant system
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