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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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GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100043-07
Not in Commercial Distribution

  • 00810054980063 ()

  • Height: 7.6 Centimeter
  • Length: 20.3 Centimeter
FR3D07

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Trel-XPress 300c, 2.5cc is made using demineralized human bone and cancellous chips mixed with poloxamer resorbable reverse phase medium. Trel-Xpress 300c is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPres3c25
In Commercial Distribution

  • 10381780112594 ()
  • M386XPRES3C251 ()

  • 2.5cc
XPres3c25

  • Bone matrix implant, human-derived
Trel-XPress 300c, 5cc is made using demineralized human bone and cancellous chips mixed with poloxamer resorbable reverse phase medium. Trel-Xpress 300c is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPres3c05
In Commercial Distribution

  • 10381780112587 ()
  • M386XPRES3C051 ()

  • 5cc
XPres3c05

  • Bone matrix implant, human-derived
Trel-XPress 300c, 10cc is made using demineralized human bone and cancellous chips mixed with poloxamer resorbable reverse phase medium. Trel-Xpress 300c is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPres3c10
In Commercial Distribution

  • M386XPRES3C101 ()
  • 10381780112570 ()

  • 10cc
XPres3c10

  • Bone matrix implant, human-derived
Electronic Sphygmomanometer is designed to measure the systolic and diastolic blood pressure of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. This is a home use device.
QINGDAO YASEE MEDICAL DEVICE CO.,LTD
JN-163B
In Commercial Distribution

  • 06972359499689 ()


  • Automatic-inflation electronic sphygmomanometer, portable, finger
The HidraWear AX device is a garment device, which is intended for the retention of a dressing in the axillar area. The HidraMed AX is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn over a brassiere and is then applied to the axillar area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Extra Extra Large
HIDRAMED SOLUTIONS LIMITED
GAX001-05
In Commercial Distribution

  • 05391535510092 ()


  • Non-adhesive device retention bandage
The HidraWear AX device is a garment device, which is intended for the retention of a dressing in the axillar area. The HidraMed AX is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn over a brassiere and is then applied to the axillar area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Extra Large
HIDRAMED SOLUTIONS LIMITED
GAX001-04
In Commercial Distribution

  • 05391535510030 ()


  • Non-adhesive device retention bandage
The HidraWear AX device is a garment device, which is intended for the retention of a dressing in the axillar area. The HidraMed AX is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn over a brassiere and is then applied to the axillar area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Large
HIDRAMED SOLUTIONS LIMITED
GAX001-03
In Commercial Distribution

  • 05391535510023 ()


  • Non-adhesive device retention bandage
The HidraWear AX device is a garment device, which is intended for the retention of a dressing in the axillar area. The HidraMed AX is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn over a brassiere and is then applied to the axillar area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Medium
HIDRAMED SOLUTIONS LIMITED
GAX001-02
In Commercial Distribution

  • 05391535510016 ()


  • Non-adhesive device retention bandage
The HidraWear AX device is a garment device, which is intended for the retention of a dressing in the axillar area. The HidraMed AX is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn over a brassiere and is then applied to the axillar area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Small
HIDRAMED SOLUTIONS LIMITED
GAX001-01
In Commercial Distribution

  • 05391535510009 ()


  • Non-adhesive device retention bandage
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