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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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IT-V Medizintechnik GmbH
P10107-216
In Commercial Distribution

  • 09120074392168 ()


  • Radiological whole-body positioner
COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile. COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
Heraeus Medical GmbH
hip L short
In Commercial Distribution

  • 04260102136878 ()
  • 04260102136854 ()
  • 04260102136861 ()
5034788

  • Orthopaedic cement spacer
COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile. COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
Heraeus Medical GmbH
hip M short
In Commercial Distribution

  • 04260102136847 ()
  • 04260102136823 ()
  • 04260102136830 ()
5034791

  • Orthopaedic cement spacer
COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile. COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
Heraeus Medical GmbH
hip S short
In Commercial Distribution

  • 04260102136816 ()
  • 04260102136793 ()
  • 04260102136809 ()
5034793

  • Orthopaedic cement spacer
AGILITY® CERAMIC BRACKET SYSTEM MBT PRESCRIPTION .022 FULL CASE HOOKS ON 3,4,5 (20 BRACKETS)
G & H Wire Company, Inc.
126K-345-22-01
In Commercial Distribution

  • 10190886015605 ()


  • Orthodontic bracket, ceramic
AGILITY® CERAMIC BRACKET SYSTEM MBT PRESCRIPTION .018 FULL CASE HOOKS ON 3,4,5 (20 BRACKETS)
G & H Wire Company, Inc.
126K-345-18-01
In Commercial Distribution

  • 10190886015599 ()


  • Orthodontic bracket, ceramic
AGILITY® CERAMIC MBT .018 UR4/5 HK -7°T 0°A BRACKETS
G & H Wire Company, Inc.
126-U4-8RK-V
In Commercial Distribution

  • 10190886015582 ()
  • 00190886015585 ()


  • Orthodontic bracket, ceramic
AGILITY® CERAMIC MBT .018 UL4/5 HK -7°T 0°A BRACKETS
G & H Wire Company, Inc.
126-U4-8LK-V
In Commercial Distribution

  • 10190886015575 ()
  • 00190886015578 ()


  • Orthodontic bracket, ceramic
AGILITY® CERAMIC MBT .022 UR4/5 HK -7°T 0°A BRACKETS
G & H Wire Company, Inc.
126-U4-2RK-V
In Commercial Distribution

  • 10190886015568 ()
  • 00190886015561 ()


  • Orthodontic bracket, ceramic
AGILITY® CERAMIC MBT .022 UL4/5 HK -7°T 0°A BRACKETS
G & H Wire Company, Inc.
126-U4-2LK-V
In Commercial Distribution

  • 10190886015551 ()
  • 00190886015554 ()


  • Orthodontic bracket, ceramic
AGILITY® CERAMIC MBT .018 UR3 HK -7°T +8°A BRACKETS
G & H Wire Company, Inc.
126-U3-8RK-V
In Commercial Distribution

  • 10190886015544 ()
  • 00190886015547 ()


  • Orthodontic bracket, ceramic
AGILITY® CERAMIC MBT .018 UL3 HK -7°T +8°A BRACKETS
G & H Wire Company, Inc.
126-U3-8LK-V
In Commercial Distribution

  • 10190886015537 ()
  • 00190886015530 ()


  • Orthodontic bracket, ceramic
AGILITY® CERAMIC MBT .022 UR3 HK -7°T +8°A BRACKETS
G & H Wire Company, Inc.
126-U3-2RK-V
In Commercial Distribution

  • 10190886015520 ()
  • 00190886015523 ()


  • Orthodontic bracket, ceramic
AGILITY® CERAMIC MBT .022 UL3 HK -7°T +8°A BRACKETS
G & H Wire Company, Inc.
126-U3-2LK-V
In Commercial Distribution

  • 10190886015513 ()
  • 00190886015516 ()


  • Orthodontic bracket, ceramic
AGILITY® CERAMIC MBT .018 UR2 +10°T +8°A BRACKETS
G & H Wire Company, Inc.
126-U2-8R-V
In Commercial Distribution

  • 10190886015506 ()
  • 00190886015509 ()


  • Orthodontic bracket, ceramic
AGILITY® CERAMIC MBT .018 UL2 +10°T +8°A BRACKETS
G & H Wire Company, Inc.
126-U2-8L-V
In Commercial Distribution

  • 10190886015490 ()
  • 00190886015493 ()


  • Orthodontic bracket, ceramic
AGILITY® CERAMIC MBT .022 UR2 +10°T +8°A BRACKETS
G & H Wire Company, Inc.
126-U2-2R-V
In Commercial Distribution

  • 10190886015483 ()
  • 00190886015486 ()


  • Orthodontic bracket, ceramic
AGILITY® CERAMIC MBT .022 UL2 +10°T +8°A BRACKETS
G & H Wire Company, Inc.
126-U2-2L-V
In Commercial Distribution

  • 10190886015476 ()
  • 00190886015479 ()


  • Orthodontic bracket, ceramic
AGILITY® CERAMIC MBT .018 UR1 +17°T +4°A BRACKETS
G & H Wire Company, Inc.
126-U1-8R-V
In Commercial Distribution

  • 10190886015469 ()
  • 00190886015462 ()


  • Orthodontic bracket, ceramic
AGILITY® CERAMIC MBT .018 UL1 +17°T +4°A BRACKETS
G & H Wire Company, Inc.
126-U1-8L-V
In Commercial Distribution

  • 10190886015452 ()
  • 00190886015455 ()


  • Orthodontic bracket, ceramic
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