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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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EZbra® breast dressing is a sterile, disposable, elastic binder (or bandage) that is intended to support and compress breasts and absorb fluids following invasive breast procedures such as aesthetic surgery, biopsy, lumpectomy, breast reduction, mastectomy, and reconstruction. The device is intended for single use and should be changed daily or according to doctor’s instructions.
EZBRA ADVANCED WOUND CARE LTD
L
In Commercial Distribution

  • 07290017224053 ()
  • 07290017224022 ()
  • 07290017224114 ()
  • 07290017224084 ()


  • Breast binder, single-use
EZbra® breast dressing is a sterile, disposable, elastic binder (or bandage) that is intended to support and compress breasts and absorb fluids following invasive breast procedures such as aesthetic surgery, biopsy, lumpectomy, breast reduction, mastectomy, and reconstruction. The device is intended for single use and should be changed daily or according to doctor’s instructions.
EZBRA ADVANCED WOUND CARE LTD
M
In Commercial Distribution

  • 07290017224046 ()
  • 07290017224015 ()
  • 07290017224107 ()
  • 07290017224077 ()


  • Breast binder, single-use
EZbra® breast dressing is a sterile, disposable, elastic binder (or bandage) that is intended to support and compress breasts and absorb fluids following invasive breast procedures such as aesthetic surgery, biopsy, lumpectomy, breast reduction, mastectomy, and reconstruction. The device is intended for single use and should be changed daily or according to doctor’s instructions.
EZBRA ADVANCED WOUND CARE LTD
S
In Commercial Distribution

  • 07290017224008 ()
  • 07290017224039 ()
  • 07290017224091 ()
  • 07290017224060 ()


  • Breast binder, single-use
Retriever Cartridge is available in addition to the Applicator Cartridge and its use is optional. The Retriever Cartridge operated by the Handle (forming the “Retriever”) is used to retrieve the anchor-suture assembly after it has been placed on ligament. Retrieval of the Implant may be followed by the placement of a new anchor-suture assembly.
ESCALA MEDICAL LTD
Mendit Retriever Set - permanent suture (ePTFE USP 0)
In Commercial Distribution

  • 07290019174202 ()
ES0517

  • Soft-tissue/mesh anchor, bioabsorbable
Retriever Cartridge is available in addition to the Applicator Cartridge and its use is optional. The Retriever Cartridge operated by the Handle (forming the “Retriever”) is used to retrieve the anchor-suture assembly after it has been placed on ligament. Retrieval of the Implant may be followed by the placement of a new anchor-suture assembly.
ESCALA MEDICAL LTD
Mendit Retriever Set - permanent suture (ePTFE 2-0)
In Commercial Distribution

  • 07290019174196 ()
ES0512

  • Soft-tissue/mesh anchor, bioabsorbable
Retriever Cartridge is available in addition to the Applicator Cartridge and its use is optional. The Retriever Cartridge operated by the Handle (forming the “Retriever”) is used to retrieve the anchor-suture assembly after it has been placed on ligament. Retrieval of the Implant may be followed by the placement of a new anchor-suture assembly.
ESCALA MEDICAL LTD
Mendit Retriever Set - Resorbable suture (PDS USP 0)
In Commercial Distribution

  • 07290019174172 ()
ES0530

  • Soft-tissue/mesh anchor, bioabsorbable
Dewin Fertilization Medium is intended for use during vitro fertilization (IVF) procedures and culture to the two pronuclei (zygote) stage of development. Dewin Fertilization Medium is also intended for washing and handling sperm and collected oocytes after aspiration prior to IVF procedures. Dewin Fertilization Medium is not intended for use in intrauterine insemination procedures
DonneVie Medical Technology(Shanghai)Co.Ltd
9341
In Commercial Distribution

  • 06972962312443 ()


  • IVF medium
Dewin Fertilization Medium is intended for use during vitro fertilization (IVF) procedures and culture to the two pronuclei (zygote) stage of development. Dewin Fertilization Medium is also intended for washing and handling sperm and collected oocytes after aspiration prior to IVF procedures. Dewin Fertilization Medium is not intended for use in intrauterine insemination procedures.
DonneVie Medical Technology(Shanghai)Co.Ltd
9340
In Commercial Distribution

  • 06972962312436 ()


  • IVF medium
Celox Rapid X-Ray Gauze is a sterile, single-use hemostatic gauze for external use. The gauze is stitch-bonded with a radiopaque strip and coated in chitosan-based hemostatic granules. The device is intended to control bleeding by forming a gel-like plug at the site of bleeding.The device may be left in place for up to 72 hours.
MEDTRADE PRODUCTS LIMITED
FG08839291
In Commercial Distribution

  • 35060206631589 ()
  • 15060206631585 ()
  • 75060206631587 ()

  • Width: 3 Inch
  • Length: 5 Feet
  • 3inch x 5ft z-fold gauze
FG08839291

  • Chitosan haemostatic agent, professional, non-bioabsorbable
Cem-Ostetic is a bio-engineered mixture of calcium-based inorganic compounds. After it is implanted, Cem-Ostetic resorbs and is later replaced by natural bone. Cem-Ostetic is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission. Cem-Ostetic is an osteoconductive putty that is intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. It is biocompatible and resorbs in the body as bone in-growth occurs.
BERKELEY ADVANCED BIOMATERIALS, LLC
CemO-30P
In Commercial Distribution

  • 00858418003836 ()
CemO-30P

  • Bone matrix implant, synthetic, non-antimicrobial
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