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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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3100B HFOV - 10190752158801

3100B Disposable Items Kit / HRCI
VYAIRE MEDICAL, INC.
775853
In Commercial Distribution

  • 10190752158801 ()
775853

  • Respiratory gas heating wire, adult
  • Carpal lunate prosthesis
  • Microbial medical gas filter, single-use
  • Breathing circuit condensate trap, single-use

Curaplex - 00815277021807

Curaplex BEMS Group UVC Kit
BOUND TREE MEDICAL, LLC
670135-KIT
In Commercial Distribution

  • 00815277021807 ()
  • 00810094570859 ()
670135-KIT

  • Peripherally-inserted central venous catheter
  • Antiseptic skin swab
  • Peripheral intravenous cannula

Curaplex - 00815277021739

Curaplex Reach Air UVC Kit
BOUND TREE MEDICAL, LLC
670126-KIT
In Commercial Distribution

  • 00815277021739 ()
  • 00810094570804 ()
670126-KIT

  • Peripherally-inserted central venous catheter
  • Antiseptic skin swab
  • Peripheral intravenous cannula

Curaplex - 00815277021708

Curaplex Northeim UVC Kit
BOUND TREE MEDICAL, LLC
670104-KIT
In Commercial Distribution

  • 00815277021708 ()
670104-KIT

  • Antiseptic skin swab
  • Peripherally-inserted central venous catheter
  • Peripheral intravenous cannula

N/A - 00841036126186

No Description
BIOMET MICROFIXATION, INC
31-3100
In Commercial Distribution

  • 00841036126186 ()
31-3100

  • Craniofacial bone screw, non-bioabsorbable
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Fluted surgical drill bit, reusable

TRAUMAONE SYSTEM - 00841036146832

No Description
BIOMET MICROFIXATION, INC
SP-2724
In Commercial Distribution

  • 00841036146832 ()
SP-2724

  • Fluted surgical drill bit, reusable
  • Craniofacial bone screw, non-bioabsorbable
  • Craniofacial fixation plate, non-bioabsorbable, non-customized

ArcPhix System - B487EXARC9030280

ArcPhix Compression Screw System The system includes the implant, two guide wires, one cannulated drill, and a driver.
Exsomed Corporation
EXARC903028
Not in Commercial Distribution

  • B487EXARC9030280 ()

  • Length: 28 Millimeter
  • Outer Diameter: 3.0 Millimeter
EXARC903028

  • Orthopaedic implant driver
  • Orthopaedic guidewire, single-use
  • Cannulated surgical drill bit, single-use
  • Orthopaedic bone screw (non-sliding)

Eagle Suture Anchor 5.5mm Kit - 00811714036441

(2) Eagle Screw-in Suture Anchor - 5.5mm (2) Eagle Knotless Suture Anchor - 5.5mm (1) Eagle Drill Guide (1) Eagle Drill 3.5mm (1) Eagle Drill 4.4mm (1) Eagle Tap 5.5mm
RESPONSIVE ORTHOPEDICS LLC
285956
In Commercial Distribution

  • 00811714036441 ()
285956

  • Tendon/ligament bone anchor, non-bioabsorbable
  • Fluted surgical drill bit, single-use
  • Surgical drill guide, single-use
  • Bone tap, single-use

Eagle Suture Anchor 4.5mm Kit - 00811714036434

(2) Eagle Screw-in Suture Anchor - 4.5mm (2) Eagle Knotless Suture Anchor - 4.75mm (1) Eagle Drill Guide (1) Eagle Drill 3.5mm (1) Eagle Drill 3.8mm (1) Eagle Tap 4.5mm
RESPONSIVE ORTHOPEDICS LLC
285955
In Commercial Distribution

  • 00811714036434 ()
285955

  • Tendon/ligament bone anchor, non-bioabsorbable
  • Fluted surgical drill bit, single-use
  • Surgical drill guide, single-use
  • Bone tap, single-use

Eagle Suture Anchor 5.5mm Kit - 00811714035932

(2) Eagle Screw-in Suture Anchor - 5.5mm (2) Eagle Knotless Suture Anchor - 5.5mm (1) Eagle Drill Guide (1) Eagle Drill 3.5mm (1) Eagle Drill 4.4mm (1) Eagle Tap 5.5mm
RESPONSIVE ORTHOPEDICS LLC
913000-5500
In Commercial Distribution

  • 00811714035932 ()
913000-5500

  • Tendon/ligament bone anchor, non-bioabsorbable
  • Fluted surgical drill bit, single-use
  • Surgical drill guide, single-use
  • Bone tap, single-use
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