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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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PERFECTEMP10 10mL SYR A2
DEN-MAT HOLDINGS, LLC
CR1220
In Commercial Distribution

  • D813CR12200 ()
CR1220

  • Dental composite resin
PERFECTEMP10 10mL SYR A3.5
DEN-MAT HOLDINGS, LLC
CR1219
In Commercial Distribution

  • D813CR12190 ()
CR1219

  • Dental composite resin
PERFECTEMP10 10mL SYR A1
DEN-MAT HOLDINGS, LLC
CR1218
In Commercial Distribution

  • D813CR12180 ()
CR1218

  • Dental composite resin
HyProCure Sinus Tarsi Implant Size 10. Indications: HyProCure is a talotarsal stabilization device used in the treatment of talotarsal dislocation and resulting sequela. The implant is designed to stabilize the talus on the tarsal mechanism to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus on the tarsal mechanism, while allowing normal talotarsal joint motion.
Gramedica
HYP-10
In Commercial Distribution

  • M621HYP100 ()

  • 10mm
HYP-10

  • Subtalar implant, non-bioabsorbable
HyProCure Sizer 10. Reusable instrument, for use with the HyProCure Sinus Tarsi Implant System. Indications: HyProCure is a talotarsal stabilization device used in the treatment of talotarsal dislocation and resulting sequela. The implant is designed to stabilize the talus on the tarsal mechanism to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus on the tarsal mechanism, while allowing normal talotarsal joint motion.
Gramedica
CP15-10-FG
In Commercial Distribution

  • M621CP1510FG0 ()
CP15-10-FG

  • Orthopaedic prosthesis implantation positioning instrument, reusable
The ResQPOD ITD 10 is indicated for the temporary increase in blood circulation.
ADVANCED CIRCULATORY SYSTEMS INC
12-0242-000
In Commercial Distribution

  • M5921202420000 ()
  • M5921202420001 ()
  • M5921202420002 ()


  • Cardiopulmonary resuscitation impedance valve, inspiratory
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600425-001
In Commercial Distribution

  • J00716004250011 ()
1600425-001

  • Dental power tool system handpiece, remotely-driven
This is a medical device.
KaVo Dental GmbH
1.003.6977
In Commercial Distribution

  • EKAV100369770 ()
10 E

  • Dental power tool system handpiece, line-powered
ALPT23 ETOH 10
UTAK LABORATORIES, INC.
ALPT23_ETOH 10
In Commercial Distribution

  • B800ALPT23ETOH105 ()
  • B800ALPT23ETOH100 ()

  • Total Volume: 1.25 Milliliter
ALPT23_ETOH 10

  • Multiple-type clinical chemistry analyte profile IVD, control
THC LEVEL 10
UTAK LABORATORIES, INC.
THC 10 U F WDH
In Commercial Distribution

  • B800THC10UFWDH5 ()
  • B800THC10UFWDH0 ()

  • Total Volume: 10 Milliliter
THC 10 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control
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