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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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Freedom Spinal Cord Stimulator System Freedom-4A Receiver Kit Channel A US
STIMWAVE TECHNOLOGIES INCORPORATED
FR4A-RCV-A0
In Commercial Distribution

  • 00859619004042 ()

  • Weight: 0.25 Gram
  • Length: 45 Centimeter
  • Outer Diameter: 1.35 Millimeter
S4R-1A US

  • Analgesic spinal cord electrical stimulation system
Automated instrument washer-disinfector with built-in connectivity for a lumens cleaning system.
Scican Ltd
C61WD-D01-LCS
In Commercial Distribution

  • 07540196000673 ()
C61WD-D01-LCS

  • Surgical utensil washer/disinfector
A non-sterile hanging triangular-shaped loop fabric intended to immobilize the arm.
Medique Products
6501B
In Commercial Distribution

  • 50347682650105 ()
  • 00347682650100 ()
6501B

  • Suspension arm sling
Phasor Drill 6.35-mm diameter, ~70-mm length + Kit (version A) with Stapler
PHASOR HEALTH LLC
PH-635-70 + PH-K-AS
In Commercial Distribution

  • B775PH63570PHKAS0 ()
PH-635-70 + PH-K-AS

  • Craniotomy power tool system, battery-powered, single-use
  • Neurosurgical procedure kit, medicated
Phasor Drill 6.35-mm diameter,~70-mm length + Kit (version A) with stapler
PHASOR HEALTH LLC
PH-635-70-D + PH-K-AS
In Commercial Distribution

  • B775PH63570DPHKAS0 ()
PH-635-70-D + PH-K-AS

  • Craniotomy power tool system, battery-powered, single-use
  • Neurosurgical procedure kit, medicated
Superelastic Nitinol Implant Style A 9 x 8 x 8mm (Single)
FUSION ORTHOPEDICS, LLC
DB-09-0808-SA1
In Commercial Distribution

  • 00819034027880 ()
DB-09-0808-SA1

  • Orthopaedic bone staple, non-adjustable, non-sterile
Superelastic Nitinol Implant System Style A 15 x 12 x 12mm
FUSION ORTHOPEDICS, LLC
DB-15-1212-SA
In Commercial Distribution

  • 00819034023516 ()
DB-15-1212-SA1

  • Orthopaedic bone staple, non-adjustable, non-sterile
Superelastic Nitinol Implant System Style A 13 x 10 x 10mm
FUSION ORTHOPEDICS, LLC
DB-13-1010-SA
In Commercial Distribution

  • 00819034023493 ()
DB-13-1010-SA1

  • Orthopaedic bone staple, non-adjustable, non-sterile
Superelastic Nitinol Implant System Style A 11 x 10 x 10mm
FUSION ORTHOPEDICS, LLC
DB-11-1010-SA
In Commercial Distribution

  • 00819034023479 ()
DB-11-1010-SA

  • Orthopaedic bone staple, non-adjustable, non-sterile
Superelastic Nitinol Implant System Style A 9 x 8 x 8mm
FUSION ORTHOPEDICS, LLC
DB-09-0808-SA
In Commercial Distribution

  • 00819034023462 ()
DB-09-0808-SA

  • Orthopaedic bone staple, non-adjustable, non-sterile
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