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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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Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS4516CT
Not in Commercial Distribution

  • M269PSS4516CT1 ()
  • 10381780117544 ()

  • .771 in L x .177 in dia
PSS4516CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS4514LT
Not in Commercial Distribution

  • M269PSS4514LT1 ()
  • 10381780117537 ()

  • .691 in L x .177 in dia
PSS4514LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS4514CT
Not in Commercial Distribution

  • M269PSS4514CT1 ()
  • 10381780117520 ()

  • .692 in L x .177 in dia
PSS4514CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Turbine type high- speed handpiece. Unit supplied by a hose, via a special ISO 9168 coupling. Anti- heat push- button bur changing mechanism. Ceramic ball bearings, 4 sprays. Optical glass rod with light.
Bien-Air Dental SA
1601153-001
In Commercial Distribution

  • J00716011530011 ()
1601153-001

  • Dental power tool system handpiece, pneumatic
Turbine type high- speed handpiece. Unit supplied by a hose, via a special ISO 9168 coupling. Anti- heat push- button bur changing mechanism. Ceramic ball bearings, 4 sprays. Optical glass rod with light.
Bien-Air Dental SA
1601152-001
In Commercial Distribution

  • J00716011520011 ()
1601152-001

  • Dental power tool system handpiece, pneumatic
AH Plus Jet Refill Kit is a 2 component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Jet is received in a syringe delivery for homogeneous mixing of both pastes.
Dentsply De Trey GmbH
667007
In Commercial Distribution

  • D0106670071 ()
  • D0106670070 ()

  • Paste
  • Weight: 15 Gram
667007

  • Endodontic filling/sealing material
Mannitol Salt Agar (MSA) test uses a selective isolation media for the enumeration of staphylococci from clinical/non-clinical materials. A change of the phenol red indicator (Mannitol fermentation) aids in differentiating staphylococci species.
BIO-MED DIAGNOSTICS, INC.
1303
In Commercial Distribution

  • B08813034 ()
  • B08813030 ()
  • B08813032 ()
21-303-001

  • Mannitol-salt Staphylococcus species agar culture medium IVD
The Integra Total Foot System mini calcaneus plate is a low profile,less invasive plate fixation for calcaneal fracture procedures. It reduces the need for a large calcaneal flap incision in most cases.
Ascension Orthopedics, Inc.
2805007
Not in Commercial Distribution

  • 10381780118305 ()
  • M26828050071 ()

  • 57.93mm L x 42.63mm W x 1.3mm H
2805007

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The Integra Total Foot System mini calcaneus plate is a low profile, less invasive plate fixation for calcaneal fracture procedures. It reduces the need for a large calcaneal flap incision in most cases.
Ascension Orthopedics, Inc.
2805006
Not in Commercial Distribution

  • 10381780118299 ()
  • M26828050061 ()

  • 46.69mm L x 16.67mm W x 1.3mm H
2805006

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The Bebe Vie is a single-use pediatric laryngoscope for intubation of toddlers to age ten.
ADROIT SURGICAL
BB-111
In Commercial Distribution

  • 00860115000612 ()
  • 00860115000681 ()


  • Rigid intubation laryngoscope, single-use
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