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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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Screw system for fixation of bone segments e.g. for horizontal or vertical augmentative grafts The kit includes dental screws TX and neccessary accessories. The bone screws have a self-tapping design and the connection between screw and screw driver is realized by a socket head or a hexalobular connection to obtain a clamping force. Dental Bone Screws are delivered non sterile. The following screws are included: 7pcs TCT09 007, 7pcs TCT09 010, 3pcs TCT10 007, 3pcs TCT10 010 7pcs TCT09 013, 7pcs TCT09 016, 3pcs TCT10 013, 3pcs TCT10 016
Hager & Meisinger Gesellschaft mit beschränkter Haftung
BTXPR
In Commercial Distribution

BTXPR

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
AlbiQuick™, for Candida albicans differentiation, 5 minute test, 25 tests per kit The new Hardy AlbiQuick™ utilizes two enzyme color reactions to produce an accurate result that’s easy to read out. AlbiQuick is performed on a convenient card with two reaction wells. Only Candida albicans possesses the enzymes that will hydrolyze the PRO and NAG compounds on the card. Incubation time is only five minutes at room temperature! Requires the use of a handheld 366nm ultra violet lamp(see Cat. no. UVL56). The old germ tube method of C. albicans identification requires several hours of incubation and tedious microscopy to produce a result. The AlbiQuick™ eliminates the need for this and other lengthy procedures. A recent study, which compared the above NAG and PRO methods to the traditional germ tube test, showed a sensitivity of 99% and a specificity of 99-100% (the germ tube test showed a sensitivity of 95% and a specificity of 99%; all isolates confirmed by API 20C). Ref: Crist, et al, J. Clin. Microbiol. 34:2616-2618. Accurate, fast, and convenient...that’s AlbiQuick™! Contains: Albiquick Test Cards (25) 00819398027298 Albiquick Reagent A (1) 00816576029051 Developer Reagent (1) 00819398028585
HARDY DIAGNOSTICS
Z121
In Commercial Distribution

  • 00819398028608 ()
Z121

  • Candida albicans/C. glabrata antigen IVD, kit, agglutination, rapid
The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver. The Spirotome Biopsy Needle Set contains: • A two-part introducer needle that consists of a cutting cannula and a trocar stylet • A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula - Injection needle • A release element This presentation has an external diameter of 10G (4 mm) and length of 150 mm.
Bioncise
SS10SP
In Commercial Distribution

  • 05407005000267 ()
  • 05407005001264 ()
SS10SP

  • Soft-tissue biopsy needle, single-use
The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver. The Spirotome Biopsy Needle Set contains: • A two-part introducer needle that consists of a cutting cannula and a trocar • A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula - Injection needle • A release element This presentation has an external diameter of 8G (5 mm) and length of 150 mm.
Bioncise
SS08SP
In Commercial Distribution

  • 05407005000250 ()
  • 05407005001257 ()
SS08SP

  • Soft-tissue biopsy needle, single-use
The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver. The Spirotome Biopsy Needle Set contains: • A two-part introducer needle that consists of a cutting cannula and a trocar stylet • A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula • A release element This presentation has an external diameter of 10G (4 mm) and length of 150 mm.
Bioncise
SS10BO
In Commercial Distribution

  • 05407005000243 ()
  • 05407005001240 ()
SS10BO

  • Soft-tissue biopsy needle, single-use
The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver. The Spirotome Biopsy Needle Set contains: • A two-part introducer needle that consists of a cutting cannula and a trocar stylet • A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula • A release element This presentation has an external diameter of 08G (5mm) and length of 150 mm.
Bioncise
SS08BO
In Commercial Distribution

  • 05407005000236 ()
  • 05407005001233 ()
SS08BO

  • Soft-tissue biopsy needle, single-use
The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver. The Spirotome Biopsy Needle Set contains: • An introducer needle that consists of a cutting cannula • A 10 mm helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula • A release element This presentation has an external diameter of 14G (2.5 mm) and length of 350 mm.
Bioncise
SS14EN1
In Commercial Distribution

  • 05407005000229 ()
  • 05407005001226 ()
SS14EN1

  • Soft-tissue biopsy needle, single-use
The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver. The Spirotome Biopsy Needle Set contains: • A two-part introducer needle that consists of a cutting cannula and a trocar stylet • A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula • A release element This presentation has an external diameter of 10G (4 mm) for use under MR.
Bioncise
SS10MR
In Commercial Distribution

  • 05407005000168 ()
  • 05407005001165 ()
SSA10MR

  • Soft-tissue biopsy needle, single-use
The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver. The Spirotome Biopsy Needle Set contains: • A two-part introducer needle that consists of a cutting cannula and a trocar stylet • A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula • A release element This presentation has an external diameter of 8G (5 mm) for use under MR.
Bioncise
SS08MR
In Commercial Distribution

  • 05407005000151 ()
  • 05407005001158 ()
SS08MR

  • Soft-tissue biopsy needle, single-use
The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver. The Spirotome Biopsy Needle Set contains: • A two-part introducer needle that consists of a cutting cannula and a trocar stylet • A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula • A release element This presentation has an external diameter of 14G (2.5 mm) and length of 60 mm.
Bioncise
SS1406
In Commercial Distribution

  • 05407005000144 ()
  • 05407005001141 ()
SS1406

  • Soft-tissue biopsy needle, single-use
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