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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FREND™ PSA Plus Linearity Kit is intended for use as an assayed linearity material for the prostate-specific antigen (PSA) on the FREND™ System. The Linearity kit is for the FREND™ System only. FREND™ PSA Plus Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution.
NanoEnTek, Inc.
FREND PSA Plus Linearity Kit
In Commercial Distribution

  • 08809317540535 ()
FLK-PSA

  • Non-blood cell primer/calibrator/control material IVD, reagent
FREND™ Free T4 Linearity Kit is intended for use as an assayed linearity material for the free thyroxine (Free T4) on the FREND™ System. The Linearity Kit is for the FREND™ System only. FREND™ Free T4 Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution.
NanoEnTek, Inc.
FREND Free T4 Linearity Kit
In Commercial Distribution

  • 08809317540528 ()
FLK-FT4

  • Non-blood cell primer/calibrator/control material IVD, reagent
This Lumbar Back Brace acts as an immobilizing device for the lumbar-sacral region and its’ primary function is to reduce pain caused by lumbago, sciatica and ischialgia. Made with semi-rigid fabric, it enjoys a structure made with self modeling and flexible stays on which a number of rigid straps slide. When the locking system is pulled and secured at the front, the inside straps stiffen the entire structure, thus effectively im- mobilizing the lumbar-sacral region. Two rigid abdominal panels are included. these panels produce intra-abdominal pressure to reduce load on discs thus reducing pain and improving post-operative outcome when used with the corset in the appropriate position. Practical and easy to wear, this brace perfectly adapts to whatever size and body type, thus ensuring maximum support and comfort at the desired tension. through a new locking technology, operated by means of two crossing bands, the closing system is totally user friendly and allows a wide range of tension settings. INDICATIONS •Lumbago, sciatica and ischialgia. •Lumbar-Sacral pain of other origin and nature. •Disc complaints. •Spondylo-arthrosis. •Osteoporosis related lumbar vertebrae complaints. •Para-vertebral lumbar muscle spasm. •Light trauma of the lumbar-sacral column. Recommended for general back pain and support.
INDACO SRL
505 2XL/3XL
In Commercial Distribution

  • 05391512286408 ()
  • 05391512282820 ()
505

  • Lumbar spine orthosis
This Lumbar Back Brace acts as an immobilizing device for the lumbar-sacral region and its’ primary function is to reduce pain caused by lumbago, sciatica and ischialgia. Made with semi-rigid fabric, it enjoys a structure made with self modeling and flexible stays on which a number of rigid straps slide. When the locking system is pulled and secured at the front, the inside straps stiffen the entire structure, thus effectively im- mobilizing the lumbar-sacral region. Two rigid abdominal panels are included. these panels produce intra-abdominal pressure to reduce load on discs thus reducing pain and improving post-operative outcome when used with the corset in the appropriate position. Practical and easy to wear, this brace perfectly adapts to whatever size and body type, thus ensuring maximum support and comfort at the desired tension. through a new locking technology, operated by means of two crossing bands, the closing system is totally user friendly and allows a wide range of tension settings. INDICATIONS •Lumbago, sciatica and ischialgia. •Lumbar-Sacral pain of other origin and nature. •Disc complaints. •Spondylo-arthrosis. •Osteoporosis related lumbar vertebrae complaints. •Para-vertebral lumbar muscle spasm. •Light trauma of the lumbar-sacral column. Recommended for general back pain and support.
INDACO SRL
505 L/XL
In Commercial Distribution

  • 05391512286392 ()
  • 05391512282813 ()
505

  • Lumbar spine orthosis
This Lumbar Back Brace acts as an immobilizing device for the lumbar-sacral region and its’ primary function is to reduce pain caused by lumbago, sciatica and ischialgia. Made with semi-rigid fabric, it enjoys a structure made with self modeling and flexible stays on which a number of rigid straps slide. When the locking system is pulled and secured at the front, the inside straps stiffen the entire structure, thus effectively im- mobilizing the lumbar-sacral region. Two rigid abdominal panels are included. these panels produce intra-abdominal pressure to reduce load on discs thus reducing pain and improving post-operative outcome when used with the corset in the appropriate position. Practical and easy to wear, this brace perfectly adapts to whatever size and body type, thus ensuring maximum support and comfort at the desired tension. through a new locking technology, operated by means of two crossing bands, the closing system is totally user friendly and allows a wide range of tension settings. INDICATIONS •Lumbago, sciatica and ischialgia. •Lumbar-Sacral pain of other origin and nature. •Disc complaints. •Spondylo-arthrosis. •Osteoporosis related lumbar vertebrae complaints. •Para-vertebral lumbar muscle spasm. •Light trauma of the lumbar-sacral column. Recommended for general back pain and support.
INDACO SRL
505 S/M
In Commercial Distribution

  • 05391512286385 ()
  • 05391512282806 ()
505

  • Lumbar spine orthosis
The Blue Line M-Brace Lumbar-Sacral Brace acts as an immobilizing device for the lumbar-sacral region and its’ primary function is to reduce pain caused by lumbago, sciatica and ischialgia. Made with semi-rigid fabric, it enjoys a structure made with self-modeling and flexible stays on which a number of rigid straps slide. When the locking system is pulled and secured at the front, the inside straps stiffen the entire structure, thus effectively immobilizing the lumbar-sacral region. Two rigid thermo-formable panels for lumbar and abdominal application are included. These panels produce intra-abdominal pressure to reduce load on discs thus reducing pain and improving post-operative outcome when used with the corset in the appropriate position. The region supported extends from the sacrococcygeal joint to T-9 vertebra. Practical and easy to wear, this brace perfectly adapts to whatever size and body type, thus ensuring maximum support and comfort at the desired tension. Through a new locking technology, operated by means of two crossing bands, the closing system is totally user friendly and allows a wide range of tension settings. INDICATIONS • Lumbago, sciatica and ischialgia. • Lumbar-Sacral pain of other origin and nature. • Disc complaints. • Spondylo-arthrosis. • osteoporosis related lumbar vertebrae complaints. • Para-vertebral lumbar muscle spasm. • Light trauma of the lumbar-sacral column. • Mouldable 15 inch back panel included.
INDACO SRL
503 2XL/3XL
In Commercial Distribution

  • 05391512286347 ()
  • 05391512282769 ()
503

  • Lumbar spine orthosis
The Blue Line M-Brace Lumbar-Sacral Brace acts as an immobilizing device for the lumbar-sacral region and its’ primary function is to reduce pain caused by lumbago, sciatica and ischialgia. Made with semi-rigid fabric, it enjoys a structure made with self-modeling and flexible stays on which a number of rigid straps slide. When the locking system is pulled and secured at the front, the inside straps stiffen the entire structure, thus effectively immobilizing the lumbar-sacral region. Two rigid thermo-formable panels for lumbar and abdominal application are included. These panels produce intra-abdominal pressure to reduce load on discs thus reducing pain and improving post-operative outcome when used with the corset in the appropriate position. The region supported extends from the sacrococcygeal joint to T-9 vertebra. Practical and easy to wear, this brace perfectly adapts to whatever size and body type, thus ensuring maximum support and comfort at the desired tension. Through a new locking technology, operated by means of two crossing bands, the closing system is totally user friendly and allows a wide range of tension settings. INDICATIONS • Lumbago, sciatica and ischialgia. • Lumbar-Sacral pain of other origin and nature. • Disc complaints. • Spondylo-arthrosis. • osteoporosis related lumbar vertebrae complaints. • Para-vertebral lumbar muscle spasm. • Light trauma of the lumbar-sacral column. • Mouldable 15 inch back panel included.
INDACO SRL
503 L/XL
In Commercial Distribution

  • 05391512286330 ()
  • 05391512282752 ()
503

  • Lumbar spine orthosis
The Blue Line M-Brace Lumbar-Sacral Brace acts as an immobilizing device for the lumbar-sacral region and its’ primary function is to reduce pain caused by lumbago, sciatica and ischialgia. Made with semi-rigid fabric, it enjoys a structure made with self-modeling and flexible stays on which a number of rigid straps slide. When the locking system is pulled and secured at the front, the inside straps stiffen the entire structure, thus effectively immobilizing the lumbar-sacral region. Two rigid thermo-formable panels for lumbar and abdominal application are included. These panels produce intra-abdominal pressure to reduce load on discs thus reducing pain and improving post-operative outcome when used with the corset in the appropriate position. The region supported extends from the sacrococcygeal joint to T-9 vertebra. Practical and easy to wear, this brace perfectly adapts to whatever size and body type, thus ensuring maximum support and comfort at the desired tension. Through a new locking technology, operated by means of two crossing bands, the closing system is totally user friendly and allows a wide range of tension settings. INDICATIONS • Lumbago, sciatica and ischialgia. • Lumbar-Sacral pain of other origin and nature. • Disc complaints. • Spondylo-arthrosis. • osteoporosis related lumbar vertebrae complaints. • Para-vertebral lumbar muscle spasm. • Light trauma of the lumbar-sacral column. • Mouldable 15 inch back panel included.
INDACO SRL
503 S/M
In Commercial Distribution

  • 05391512286323 ()
  • 05391512282745 ()
503

  • Lumbar spine orthosis
This ACTIVDAY Lumbar-Sacral Brace acts as an immobilizing device for the lumbar-sacral region and its’ primary function is to reduce pain caused by lumbago, sciatica and ischialgia. Made with semi-rigid fabric, it enjoys a structure made with eight self modeling and flexible steel stays on which a number of rigid straps slide. When the locking system is pulled and secured at the front, the inside straps stiffen the entire structure, thus effectively immobilizing the lumbar-sacral region. Two rigid thermo-formable panels for lumbar and abdominal application are included. These panels produce intra-abdominal pressure to reduce load on discs thus reducing pain and improving post-operative outcome when used with the corset in the appropriate position. The supported region extends from the sacrococcygeal joint to T-9 vertebra. Practical and easy to wear, this brace perfectly adapts to whatever size and body type, thus ensuring maximum support and comfort at the desired tension. Through a new locking technology, operated by means of two crossing bands, the closing system is totally user friendly and allows a wide range of elastic tension settings. INDICATIONS •Lumbago, sciatica and ischialgia.. •Lumbar-Sacral pain of other origin and nature. •Disc complaints. •Spondylo-arthrosis. •Osteoporosis related lumbar vertebrae complaints. •Para-vertebral lumbar muscle spasm. •Light trauma of the lumbar-sacral column.
INDACO SRL
500 4XL
In Commercial Distribution

  • 05391512286019 ()
  • 05391512281212 ()
500

  • Lumbar spine orthosis
This ACTIVDAY Lumbar-Sacral Brace acts as an immobilizing device for the lumbar-sacral region and its’ primary function is to reduce pain caused by lumbago, sciatica and ischialgia. Made with semi-rigid fabric, it enjoys a structure made with eight self modeling and flexible steel stays on which a number of rigid straps slide. When the locking system is pulled and secured at the front, the inside straps stiffen the entire structure, thus effectively immobilizing the lumbar-sacral region. Two rigid thermo-formable panels for lumbar and abdominal application are included. These panels produce intra-abdominal pressure to reduce load on discs thus reducing pain and improving post-operative outcome when used with the corset in the appropriate position. The supported region extends from the sacrococcygeal joint to T-9 vertebra. Practical and easy to wear, this brace perfectly adapts to whatever size and body type, thus ensuring maximum support and comfort at the desired tension. Through a new locking technology, operated by means of two crossing bands, the closing system is totally user friendly and allows a wide range of elastic tension settings. INDICATIONS •Lumbago, sciatica and ischialgia.. •Lumbar-Sacral pain of other origin and nature. •Disc complaints. •Spondylo-arthrosis. •Osteoporosis related lumbar vertebrae complaints. •Para-vertebral lumbar muscle spasm. •Light trauma of the lumbar-sacral column.
INDACO SRL
500 3XL
In Commercial Distribution

  • 05391512286002 ()
  • 05391512281205 ()
500

  • Lumbar spine orthosis
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