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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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OPHTHAMIC SOLUTION, INC.
Intraocular Lens
Not in Commercial Distribution

  • 00859228007007 ()


  • Posterior-chamber intraocular lens, pseudophakic
PONTiS Dual Suture-Crimp Implant kit with Multifilament Stainless Steel Sutures and SS Crimp Each Kit contains: 1x Dual #3-0 MFSS sutures with 2 straight needles 1x SS Crimp collar Supplied pouched, sterilized with EO
PONTIS ORTHOPAEDICS, LLC
400-3020
In Commercial Distribution

  • 00859210006117 ()

  • Suture size 000
400-3020

  • Metallic suture, multifilament
PONTiS Achilles Tendon Repair Implant kit with Multifilament Stainless Steel Sutures and SS Crimp. Each Kit contains: 1x size #3 MFSS suture with 2 curved needles (white wrap) 1x size #3 MFSS suture with 2 curved needles (black wrap) 1x SS Crimp Collar for #3 SS sutures Supplied pouched, sterilized with EO.
PONTIS ORTHOPAEDICS, LLC
600-4001
In Commercial Distribution

  • 00859210006070 ()

  • Size #3 Suture
600-4001

  • Metallic suture, multifilament
PONTiS Crimp Collar for Flexor Tendon Repair Each Unit contains: 1x SS Crimp Collar for use with PONTiS size #3-0 multifilament SS sutures. Supplied pouched, sterilized with EO.
PONTIS ORTHOPAEDICS, LLC
401-3006
In Commercial Distribution

  • 00859210006032 ()
401-3006

  • Metallic suture, multifilament
PONTiS 3mm Anchor with Anchor Driver for Flexor Tendon Repair Each Kit contains: 1x 3mm Anchor with Driver handle Anchor has size #3-0 multifilament SS suture Each end of SS suture has pre-attached straight needles. Supplied pouched, sterilized with EO.
PONTIS ORTHOPAEDICS, LLC
400-3031
In Commercial Distribution

  • 00859210006025 ()

  • Length: 4.5 Millimeter
  • Outer Diameter: 3 Millimeter
400-3031

  • Tendon/ligament bone anchor, non-bioabsorbable
PONTiS Flexor Tendon Repair Implant kit with Multifilament Stainless Steel Sutures and SS Crimp. Each Kit contains: 1x size #3-0 MFSS suture with 2 curved needles (white wrap) 1x size #3-0 MFSS suture with 2 curved needles (black wrap) 1x SS Crimp Collar Supplied pouched, sterilized with EO.
PONTIS ORTHOPAEDICS, LLC
400-3011
In Commercial Distribution

  • 00859210006001 ()

  • 3-0 suture size
400-3011

  • Metallic suture, multifilament
BAROSTIM NEO Model 1037 Carotid Sinus Lead Kit
CVRX, INC.
1037
In Commercial Distribution

  • 00859144004470 ()
100063-222

  • Baroreceptor electrical stimulation system
BAROSTIM NEO Model 1036 Carotid Sinus Lead Kit (US Commercial)
CVRX, INC.
1036
In Commercial Distribution

  • 00859144004463 ()
100063-212

  • Baroreceptor electrical stimulation system
Model 5010 Carotid Sinus Lead Repair Kit (US Commercial)
CVRX, INC.
5010
In Commercial Distribution

  • 00859144004456 ()
100056-202

  • Baroreceptor electrical stimulation system
Model 9010 Programmer System (US Commercial)
CVRX, INC.
9010
In Commercial Distribution

  • 00859144004449 ()
100055-202

  • Baroreceptor electrical stimulation system
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