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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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4.8mm Diameter, 4.8mm Platform TG Implant Length 10mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/4TG10S2
In Commercial Distribution

  • 00842448114273 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 8mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/4TG8S2
In Commercial Distribution

  • 00842448114259 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 14.0mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/4TG14R1
In Commercial Distribution

  • 00842448114228 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 10.0mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/4TG10S1
In Commercial Distribution

  • 00842448114198 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 10.0mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/4TG10R1
In Commercial Distribution

  • 00842448114181 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 8mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/4TG8R1
In Commercial Distribution

  • 00842448114167 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 14mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-41/4TG14S2
In Commercial Distribution

  • 00842448114150 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 12mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-41/4TG12S2
In Commercial Distribution

  • 00842448114136 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 10mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-41/4TG10S2
In Commercial Distribution

  • 00842448114112 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 14mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG14R1
In Commercial Distribution

  • 00842448114068 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 12mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG12S1
In Commercial Distribution

  • 00842448114051 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 12mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG12R1
In Commercial Distribution

  • 00842448114044 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 10mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG10S1
In Commercial Distribution

  • 00842448114037 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 8mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG8R1
In Commercial Distribution

  • 00842448114006 ()


  • Dental implant system
3.3mm Diameter, 4.8mm Platform TG Implant Length 14mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG14S1
In Commercial Distribution

  • 00842448113993 ()


  • Dental implant system
3.3mm Diameter, 4.8mm Platform TG Implant Length 14mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG14R1
In Commercial Distribution

  • 00842448113986 ()


  • Dental implant system
3.3mm Diameter, 4.8mm Platform TG Implant Length 12mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG12S1
In Commercial Distribution

  • 00842448113979 ()


  • Dental implant system
3.3mm Diameter, 4.8mm Platform TG Implant Length 12mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG12R1
In Commercial Distribution

  • 00842448113962 ()


  • Dental implant system
3.3mm Diameter, 4.8mm Platform TG Implant Length 10mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG10S1
In Commercial Distribution

  • 00842448113955 ()


  • Dental implant system
3.3mm Diameter, 4.8mm Platform TG Implant Length 10mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG10R1
In Commercial Distribution

  • 00842448113948 ()


  • Dental implant system
3.3mm Diameter, 4.8mm Platform TG Implant Length 8mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG8S1
In Commercial Distribution

  • 00842448113931 ()


  • Dental implant system
3.3mm Diameter, 4.8mm Platform TG Implant Length 8mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG8R1
In Commercial Distribution

  • 00842448113924 ()


  • Dental implant system
Open width8±1mm the max OD of insertion part 2.6mm working length 2350mm coated
Micro-Tech (Nanjing) Co., Ltd.
ROCC-C-26-235-C
Not in Commercial Distribution

  • 26932503530228 ()
  • 16932503530221 ()
  • 06932503530224 ()
ROCC-C-26-235-C

  • Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
TG Ab QC Kit - Atellica IM - CLT 2 x 3 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995465
In Commercial Distribution

  • 00630414597928 ()
10995465

  • Thyroglobulin antibody IVD, control
TG Ab - Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995464
In Commercial Distribution

  • 00630414597911 ()
10995464

  • Thyroglobulin antibody IVD, control
Convenience kit containing Zinc PVA, Formalin and C&S Vials.
MEDICAL CHEMICAL CORPORATION
891-03
In Commercial Distribution

  • M445891030 ()
  • M445891031 ()
891-03

  • Fixative, metallic
  • 10% Neutral buffered formalin IVD
  • Carey-Blair transport medium IVD
The AS-OBGYN Information System is a PACS system that automates the managment of patient information. It is intended to be used by obstetricians, gynecologists, perinatologists, radiologists, and cardiologists.
Asw Software, LLC
10
In Commercial Distribution

  • 00860010575307 ()


  • Ultrasound imaging system application software
The NeoCoil 1 .5T GEM Flex Coil is a receive-only phased array coil system for imaging the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations. The NecCoil 1 .5T GEM Flex Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.
NEOCOIL, LLC
10
In Commercial Distribution

  • 00856181003107 ()


  • MRI system coil, radio-frequency
Picis Weight Based Dose Converter: The Picis Weight Based Dose Converter is designed for use by trained clinicians to calculate any individual patient’s dose for a given agent based on a weight based determination by the clinician.
Picis Clinical Solutions, Inc.
10
In Commercial Distribution

  • 00851831007085 ()


  • Patient health record information system application software
Picis Perioperative and Critical Care: An EMR system used in high acuity areas of the hospital (OR, ICU, Preop, PACU). A patient record is populated with information such as healthcare professionals, medical devices, and HIS/lab systems.
Picis Clinical Solutions, Inc.
10
In Commercial Distribution

  • 00851831007078 ()


  • Patient health record information system application software
Grid Pad Go 10, speech generating device
Talk To ME Technologies, LLC
10
In Commercial Distribution

  • 00850041729190 ()


  • Voice synthesizer/digitizer
Talk Pad 10: Wego Edition Speech Generating Device
Talk To ME Technologies, LLC
10
In Commercial Distribution

  • 00850041729138 ()


  • Voice synthesizer/digitizer
zuvo 10 speech generating device
Talk To ME Technologies, LLC
10
In Commercial Distribution

  • 00850041729046 ()


  • Voice synthesizer/digitizer
No Description
Merete GmbH
10
In Commercial Distribution

  • 04048266131812 ()

  • step: 10 mm
FH14010

  • Orthopaedic fixation plate, non-bioabsorbable
Dental surgery treatment planning software
Dental Wings GmbH
10
In Commercial Distribution

  • D835CODX200 ()
  • D835CODX1 ()
  • D835CODX201 ()
  • D835CODX202 ()


  • Diagnostic x-ray digital imaging system workstation
ProOcular Daily Disposable Contact Lens Power -10
CARLSBAD TECHNOLOGY INC.
-10
Not in Commercial Distribution

  • 40816816880655 ()
  • 30816816880658 ()
  • 10816816880654 ()
  • 00816816880657 ()


  • Soft corrective contact lens, daily-disposable
No Description
Ad-Tech Medical Instrument Corporation
10
In Commercial Distribution

  • 00841823109712 ()
BF08R-SP21X-0C3

  • Depth electrode
Nova 10/10+ Analyzer w/ Printer /Dilutor
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 10385480539644 ()
  • 00385480539647 ()
53964

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Nova 10/10+ Analyzer w/ Printer / Primary Tube Auto Sampler
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 10385480539637 ()
  • 00385480539630 ()
53963

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
NOVA 10 URINE DILUENT
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 00385480161381 ()
16138

  • Buffered sample diluent IVD, manual
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