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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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EASS - 09353903030003

Griplasty System - Base of Thumb with Needles
FIELD ORTHOPAEDICS PTY LTD
1
In Commercial Distribution

  • 09353903030003 ()
GPBOTN

  • Tendon/ligament bone anchor, non-bioabsorbable

ACUFEX Meniscal Root Repair - 00885556533277

MENISCAL ROOT REPAIR PACK WITH ULTRATAPE SUTURE
Smith & Nephew, Inc.
71935068
In Commercial Distribution

  • 00885556533277 ()
71935068

  • Suturing unit, single-use
  • Polyolefin/fluoropolymer suture, multifilament
  • Orthopaedic fixation plate, non-bioabsorbable

HERTRA KIT - 18032919890259

Kit #3 includes a semirigid pre-shaped mesh with hole knitted with Polypropylene monofilament and a tridimensional plug with a round base.The base is made of macroporous mesh, the tip is made of rigid mesh, both knitted with Polypropylene monofilament.
HERNIAMESH SRL
H2T25
In Commercial Distribution

  • 18032919890259 ()


  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

MAXIFLO™ - 05037881151984

MAXIFLO ePTFE Vascular Prosthesis Wrap with Unity Construction ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE SUPPORT.
VASCUTEK LTD
T1008P
Not in Commercial Distribution

  • 05037881151984 ()

  • Lumen/Inner Diameter: 8 Millimeter
  • Length: 10 Centimeter
T1008P

  • Synthetic vascular graft

CODMAN® HAKIM® - 10381780535454

Programmable Valve with Unitized RICKHAM® Reservoir (2cm Arm) and Unitized Clear Distal Catheter with Barium Stripe 120cm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
NS0310A
In Commercial Distribution

NS-0310A

  • Cerebrospinal fluid shunt valve

CODMAN® HAKIM® BACTISEAL® - 10381780525172

CODMAN® HAKIM® BACTISEAL® Shunt System Clear with Barium Stripe 15cm Ventricular Catheter with Centimeter Markings
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
NS5048
In Commercial Distribution

  • 10381780525172 ()

  • Length: 15 Centimeter
NS5048

  • Intracerebral infusion/drainage catheter, long-term

ARROW - 10801902095333

Peripherally Inserted Central Catheter Set with Blue FlexTip(R) Catheter Seldinger Access Set with 130 cm Marked Wire
TELEFLEX INCORPORATED
IPN033352
In Commercial Distribution

  • 20801902095330 ()
  • 10801902095333 ()
PR-05041-LW

  • Peripherally-inserted central venous catheter

ARROW - 10801902094572

Pressure Injectable PICC Kit with Blue FlexTip(R) Catheter, Seldinger Technique with 130 cm Platinum Tipped, Marked Wire
TELEFLEX INCORPORATED
IPN032722
In Commercial Distribution

  • 20801902094579 ()
  • 10801902094572 ()
ASK-05052-CHM

  • Peripherally-inserted central venous catheter

ARROW - 10801902158908

PICC Peripherally Inserted Central Catheter Set with Blue FlexTip(R) Catheter Seldinger Access Set with 45 cm Wire
TELEFLEX INCORPORATED
IPN914871
In Commercial Distribution

  • 20801902158905 ()
  • 10801902158908 ()
PR-05041

  • Peripherally-inserted central venous catheter

Atos Medical - 00817126020511

Laryngectomy Pulmonary Kit 9/55 With Provox® LaryTube™ with Ring and Provox® OptiDerm™ Adhesive
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020511 ()
2010-27

  • Tracheoesophageal speech valve, indwelling
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