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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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No Description
GYNEX CORPORATION
16-103
In Commercial Distribution

  • GYNX161031 ()
  • GYNX161030 ()


  • Hygroscopic cervical dilator
Patient-interface for EEG ambulatory recorder
EB NEURO SPA
B8830073320
In Commercial Distribution

  • 08056446900956 ()


  • Electroencephalographic ambulatory recorder
Patient-interface for EEG ambulatory recorder
EB NEURO SPA
B8830073310
In Commercial Distribution

  • 08056446900949 ()


  • Electroencephalographic ambulatory recorder
Patient-interface for EEG ambulatory recorder
EB NEURO SPA
B9630073000
In Commercial Distribution

  • 08056446900055 ()


  • Electroencephalographic ambulatory recorder
Patient-interface for EEG ambulatory recorder
EB NEURO SPA
B9630073300
In Commercial Distribution

  • 08056446900048 ()


  • Electroencephalographic ambulatory recorder
USB interface for EEG ambulatory recorder
EB NEURO SPA
B8830073000
In Commercial Distribution

  • 08056446900024 ()


  • Electroencephalographic ambulatory recorder
EEG Long Term-Abulatory Recorder
EB NEURO SPA
B9700073000
In Commercial Distribution

  • 08056446900017 ()


  • Electroencephalographic ambulatory recorder
EEG Long Term-Abulatory System
EB NEURO SPA
B9800073000
In Commercial Distribution

  • 08056446900000 ()


  • Electroencephalographic ambulatory recorder
Kit contents: One dilateria; thick (5mm), 2 gauze sponge envelops and IFU
Coopersurgical, Inc.
MX230
Not in Commercial Distribution

  • 60888937003323 ()
  • 00888937003321 ()

  • Outer Diameter: 5 Millimeter


  • Hygroscopic cervical dilator
Kit contents: One dilateria, medium (4mm); 2 gauze sponge envelopes and IFU
Coopersurgical, Inc.
MX220
Not in Commercial Distribution

  • 60888937003316 ()
  • 00888937003314 ()

  • Outer Diameter: 4 Millimeter


  • Hygroscopic cervical dilator
Kit contents: One dilateria, thin (3mm), 2 gauze sponge envelopes and IFU
Coopersurgical, Inc.
MX210
Not in Commercial Distribution

  • 60888937003309 ()
  • 00888937003307 ()

  • Outer Diameter: 3 Millimeter


  • Hygroscopic cervical dilator
Kit contents: One dilateria, extra thick (6mm), 2 gauze sponge envelopes and IFU
Coopersurgical, Inc.
MX240
Not in Commercial Distribution

  • 60888937003330 ()
  • 00888937003338 ()

  • Outer Diameter: 6 Millimeter


  • Hygroscopic cervical dilator
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
OSANG HEALTHCARE Co., Ltd.
ILM-0001A
In Commercial Distribution

  • 08809115905444 ()


  • Total cholesterol lipid IVD, kit, chemiluminescent immunoassay, rapid
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
Easyliner - Size 24
Alps South, LLC
ELPX-24
In Commercial Distribution

  • 00713980002017 ()


  • External limb prosthesis socket liner
Venti-Scan 24" Tubing
BIODEX MEDICAL SYSTEMS, INC.
177-092
In Commercial Distribution

  • 00718175001929 ()
  • 30718175001951 ()
  • 20718175001947 ()
  • 10718175001933 ()
177-092

  • Radioaerosol administration set
#24 Cement Spatula
HU-FRIEDY MFG. CO., LLC
CS24
In Commercial Distribution

  • 10889950007218 ()
CS24

  • Dental spatula, reusable
24" Tubing Extender
REPRO MED SYSTEMS, INC.
FEXT
In Commercial Distribution

  • 10659443000695 ()
  • 00659443000698 ()

  • Length: 24 Inch
FEXT

  • Mechanical infusion pump administration set
SEXL 24 Spatula
HU-FRIEDY MFG. CO., LLC
3U0010
In Commercial Distribution

  • 10889950123734 ()
3U0010

  • Dental spatula, reusable
Ortho Deck 24
Ergonomic Products, Inc.
D1F2
In Commercial Distribution

  • 00858308006527 ()
D1F2

  • Dental delivery system
Prefense 24" display
Nihon Kohden Digital Health Solutions, LLC
EDNS-WS24
In Commercial Distribution

  • 00851725007030 ()
EDNS-WS24

  • Centralized patient monitor
24" Tubing Extension
CORK MEDICAL, LLC
CSP-100-ES-EXT
In Commercial Distribution

  • 00851675007081 ()


  • Negative-pressure wound therapy system dressing set
FLEXTILT 24 Chair
MED-MIZER, INC.
FLEXTILT 24
In Commercial Distribution

  • 00852195007179 ()


  • Assistive ergonomic chair, manually-adjusted
Cart 24 Inch
ST. JUDE MEDICAL, INC.
H701312
In Commercial Distribution

  • 05415067013125 ()
H701312

  • Cardiac catheterization monitoring system
OneBite Arches (24)
Precision Dental Products LLC
OBA024
In Commercial Distribution

  • 00850031761476 ()
OBA024

  • Bite registration rim
DMB RL 24
World Class Technology Corporation
33.30.220.00024
In Commercial Distribution

  • 00840273918424 ()
33.30.220.00024

  • Orthodontic metal band
DMB LU 24
World Class Technology Corporation
33.30.110.00024
In Commercial Distribution

  • 00840273918080 ()
33.30.110.00024

  • Orthodontic metal band
DMB RU 24
World Class Technology Corporation
33.30.120.00024
In Commercial Distribution

  • 00840273917748 ()
33.30.120.00024

  • Orthodontic metal band
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