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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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Safety Subcutaneous Hydration Kit (HydoDermoClysis)
Synchronis Medical, LLC
4818-80000
In Commercial Distribution

  • 00850015884610 ()
  • 00850015884603 ()
4818-80000

  • Peripheral intravenous catheterization support kit
GENERAL LAPAROSCOPY
MEDLINE INDUSTRIES, INC.
DYNJ903450C
In Commercial Distribution

  • 10193489667844 ()
DYNJ903450C

  • General surgical procedure kit, non-medicated, single-use
IV Start Kit w/18ga Safety Cath
Synchronis Medical, LLC
4818-62502
In Commercial Distribution

  • 00850015884269 ()
  • 00850015884252 ()
4818-62502

  • Peripheral intravenous catheterization support kit
JACKSON CARDIAC CATH PACK
MEDLINE INDUSTRIES, INC.
DYNJ0372019L
In Commercial Distribution

  • 10193489667714 ()
  • 40193489667715 ()
DYNJ0372019L

  • General surgical procedure kit, non-medicated, single-use
MINOR
MEDLINE INDUSTRIES, INC.
DYNJ903445C
In Commercial Distribution

  • 10193489667639 ()
DYNJ903445C

  • General surgical procedure kit, non-medicated, single-use
MAJOR VAG
MEDLINE INDUSTRIES, INC.
DYNJ903446C
In Commercial Distribution

  • 10193489667622 ()
DYNJ903446C

  • General surgical procedure kit, non-medicated, single-use
LEFT HEART KIT-KETTERING/SOIN
MEDLINE INDUSTRIES, INC.
SAMPC0578
In Commercial Distribution

  • 10193489667615 ()
SAMPC0578

  • General surgical procedure kit, non-medicated, single-use
KIT CONTROL - PORTER REGIONAL
MEDLINE INDUSTRIES, INC.
SAMPC0579
In Commercial Distribution

  • 10193489667608 ()
SAMPC0579

  • General surgical procedure kit, non-medicated, single-use
Tibial Cutting guide is placed within a tray, held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves.
Canary Medical USA LLC
43-5907-080-29
In Commercial Distribution

  • 00850015699085 ()


  • Device sterilization/disinfection container, reusable
The Impaction Sleeve is a reusable (provided non-sterile), surgical instrument used to assist in attaching the CTE implant to the Zimmer Biomet Persona® Tibial Baseplate. The Impaction Sleeve protects the implant’s electronic components from impaction forces that occur during assembly.
Canary Medical USA LLC
43-5399-001-14
In Commercial Distribution

  • 00850015699061 ()


  • Orthopaedic implant impactor, reusable
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