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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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Geistlich Pharma AG
500499
In Commercial Distribution

  • 07610221013142 ()

  • Weight: 3 Gram
  • Particle diameter: 2-4 mm
-

  • Bone matrix implant, animal-derived, bioabsorbable
Pressure Monitoring Lines 24" Red Injection Line w/Male & Female Luer Lock Connectors
ARGON MEDICAL DEVICES, INC.
040302005A
Not in Commercial Distribution

  • 20886333201277 ()
  • 00886333201273 ()

  • 24" Red Injection Line
040302005A

  • Radiographic procedure tubing
POWERSPIN™ BX CENTRIFUGE, VARIABLE SPEED 1,000-13,000 RPM WITH 8 PLACE TUBE ROTOR, 24 PLACE MICROHEMATOCRIT ROTOR AND 24 PLACE MICROCENTRIFUGE ROTOR, 110 V
UNITED PRODUCTS & INSTRUMENTS
C885
In Commercial Distribution

  • 00816668020096 ()
C885

  • Microhaematocrit centrifuge IVD
Nasal Alar SpO2 Sensor MLT CPTL, 24/CS. 1 case of Philips Nasal Alar single patient use, multi-compatible SpO2 sensors, 24 sensors per case
Philips Medical Systems Hsg
Nasal Alar SpO2 Sensor MLT CPTL, 24/CS
In Commercial Distribution

  • 20884838097548 ()
  • 00884838097544 ()
989803205391

  • Pulse oximeter probe, single-use
PORCELAIN REPAIR/PFM KIT
DEN-MAT HOLDINGS, LLC
030125500
In Commercial Distribution

  • D8130301255000 ()
030125500

  • Dental etching solution
This is a medical device.
KaVo Dental GmbH
1.006.1957
In Commercial Distribution

  • EKAV100619570 ()
rootplaner Tip No 24 A

  • Ultrasonic dental scaling/debridement system
Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
287361244
In Commercial Distribution

  • 09421028118491 ()
287361244

  • Orthopaedic inorganic implant inserter/extractor, reusable
Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
287361243
In Commercial Distribution

  • 09421028118484 ()
287361243

  • Orthopaedic inorganic implant inserter/extractor, reusable
Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
287361242
In Commercial Distribution

  • 09421028118415 ()
287361242

  • Orthopaedic inorganic implant inserter/extractor, reusable
Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
287361241
In Commercial Distribution

  • 09421028118408 ()
287361241

  • Orthopaedic inorganic implant inserter/extractor, reusable
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