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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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ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812389
In Commercial Distribution

  • 00841549103452 ()


  • Dental implant suprastructure, permanent, preformed
ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812388
In Commercial Distribution

  • 00841549103445 ()


  • Dental implant suprastructure, permanent, preformed
ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812387
In Commercial Distribution

  • 00841549103438 ()


  • Dental implant suprastructure, permanent, preformed
No Description
Astar Orthodontics Inc.
1212-55-345H
In Commercial Distribution

  • 06973329320095 ()


  • Orthodontic bracket, metal
No Description
Astar Orthodontics Inc.
1212-55-3H
In Commercial Distribution

  • 06973329320088 ()


  • Orthodontic bracket, metal
RENASYS EDGE Carry Straps
SMITH & NEPHEW MEDICAL LIMITED
66803137
In Commercial Distribution

  • 05000223501150 ()
  • 05000223501143 ()

  • 42x135x12 milimeter W x H x D (approximate dimensions with strap at longest)
66803137

  • Negative-pressure wound therapy system, electric, reusable
Gravity Compensating Accessory, Low Pressure Range (White)
NATUS MEDICAL INCORPORATED
NT903430
In Commercial Distribution


  • Additional Resistance to Flow at 5ml/h, Horizontal Orientation < 30mmH2O, Vertical Orientation: 140-170mmH2O
NT903430

  • Ventriculo-peritoneal/atrial shunt
Gravity Compensating Accessory, Medium Pressure Range (Yellow)
NATUS MEDICAL INCORPORATED
NT903435
In Commercial Distribution


  • Additional Resistance to Flow at 5ml/h, Horizontal Orientation < 30mmH2O, Vertical Orientation: 200-250mmH2O
NT903435

  • Ventriculo-peritoneal/atrial shunt
The Gravity Compensating Accessory (GCA) is designed to counterbalance gravity’s effects on the fluid column within the drainage catheter of an implanted shunt system. The GCA consists of a silicone elastomer encased stainless steel housing with a ruby ball held in a stainless steel seat (in the vertical orientation) by two to four stainless steel balls. In the horizontal orientation, a minimal resistance to flow (<30mmH2O at 5ml/h) is added to the system, and in the vertical orientation: 140-170, 200-250 or 260-320mmH2O (at 5ml/h).
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
903435
Not in Commercial Distribution

  • 10381780033523 ()
  • M2729034351 ()

  • Additional Resistance to Flow at 5ml/h, Horizontal Orientation < 30mmH2O, Vertical Orientation: 200-250mmH2O
903435

  • Ventriculo-peritoneal/atrial shunt
The Gravity Compensating Accessory (GCA) is designed to counterbalance gravity’s effects on the fluid column within the drainage catheter of an implanted shunt system. The GCA consists of a silicone elastomer encased stainless steel housing with a ruby ball held in a stainless steel seat (in the vertical orientation) by two to four stainless steel balls. In the horizontal orientation, a minimal resistance to flow (<30mmH2O at 5ml/h) is added to the system, and in the vertical orientation: 140-170, 200-250 or 260-320mmH2O (at 5ml/h).
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
903430
Not in Commercial Distribution

  • 10381780033516 ()
  • M2729034301 ()

  • Additional Resistance to Flow at 5ml/h, Horizontal Orientation < 30mmH2O, Vertical Orientation: 140-170mmH2O
903430

  • Ventriculo-peritoneal/atrial shunt
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