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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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MENTOR MemoryShape Breast Implant - 00081317005117

Tall Height, Moderate Plus Profile Silicone Gel-Filled Breast Implant, 555cc |Textured|Contour|Silicone|
MENTOR TEXAS L.P.
3341409
In Commercial Distribution

  • 00081317005117 ()
334-1409

  • Silicone gel-filled breast implant, textured-surface

MENTOR MemoryShape Breast Implant - 00081317005100

Tall Height, Moderate Plus Profile Silicone Gel-Filled Breast Implant, 495cc |Textured|Contour|Silicone|
MENTOR TEXAS L.P.
3341359
In Commercial Distribution

  • 00081317005100 ()
334-1359

  • Silicone gel-filled breast implant, textured-surface

MENTOR MemoryShape Breast Implant - 00081317005094

Tall Height, Moderate Plus Profile Silicone Gel-Filled Breast Implant, 445cc |Textured|Contour|Silicone|
MENTOR TEXAS L.P.
3341309
In Commercial Distribution

  • 00081317005094 ()
334-1309

  • Silicone gel-filled breast implant, textured-surface

Avalon Biomed NeoSEALER Flo Starter Kit 2.2 g (Int'l) - 00850008515125

For use in obturating root canals as part of orthograde root canal therapy with gutta percha.
NUSMILE, LTD.
ANSIK
In Commercial Distribution

  • 00850008515125 ()

  • Weight: 2.2 Gram


  • Hygroscopic dental cement

Aaris Acrylic Intraocular lens(IOL) - 00884872025145

No Description
Aaren Scientific Inc.
EC-3 PAL
In Commercial Distribution

  • 00884872025145 ()


  • Posterior-chamber intraocular lens, pseudophakic

AMDS Hybrid Prosthesis ("AMDS") - 00877234001338

40mm (Classic) Straight Stent (28mm collar)
Artivion, Inc.
K038895
In Commercial Distribution

  • 00877234001338 ()

  • Catheter Length: 527 Millimeter
  • Aortic Stent Proximal Diameter: 20-35mm
  • Aortic Stent Distal Diameter: 25-35mm
  • Aortic Stent Minimum Length:153mm
  • Aortic Stent Maximum Length: 207mm
  • Stent Collar Diameter: 28mm
AMDS40c

  • Bare-metal aortic stent

AMDS Hybrid Prosthesis ("AMDS") - 00877234001321

40mm – 30mm (Classic) Tapered Stent (28mm collar)
Artivion, Inc.
K038896
In Commercial Distribution

  • 00877234001321 ()

  • Catheter Length: 527 Millimeter
  • Aortic Stent Proximal Diameter: 20-35mm
  • Aortic Stent Distal Diameter: 20-24mm
  • Aortic Stent Minimum Length:159mm
  • Aortic Stent Maximum Length: 203mm
  • Stent Collar Diameter: 28mm
AMDS4030c

  • Bare-metal aortic stent

AMDS Hybrid Prosthesis ("AMDS") - 00877234001222

55mm – 40mm Tapered Stent (32mm collar)
Artivion, Inc.
K039423
In Commercial Distribution

  • 00877234001222 ()

  • Catheter Length: 546 Millimeter
  • Aortic Stent Proximal Diameter: 36-45mm
  • Aortic Stent Distal Diameter: 27-35mm
  • Aortic Stent Minimum Length:185mm
  • Aortic Stent Maximum Length:211mm
  • Stent Collar Diameter: 32mm
AMDS5540

  • Bare-metal aortic stent

AMDS Hybrid Prosthesis ("AMDS") - 00877234001208

40mm – 30mm Tapered Stent (24mm collar)
Artivion, Inc.
K039421
In Commercial Distribution

  • 00877234001208 ()

  • Catheter Length: 527 Millimeter
  • Aortic Stent Proximal Diameter: 20-35mm
  • Aortic Stent Distal Diameter: 20-24mm
  • Aortic Stent Minimum Length:159mm
  • Aortic Stent Maximum Length:203mm
  • Stent Collar Diameter: 24mm
AMDS4030

  • Bare-metal aortic stent

AMDS Hybrid Prosthesis ("AMDS") - 00877234001192

40mm Straight Stent (24mm collar)
Artivion, Inc.
K039420
In Commercial Distribution

  • 00877234001192 ()

  • Catheter Length: 527 Millimeter
  • Aortic Stent Proximal Diameter: 20-35mm
  • Aortic Stent Distal Diameter: 25-35mm
  • Aortic Stent Minimum Length:153mm
  • Aortic Stent Maximum Length:207mm
  • Stent Collar Diameter: 24mm
AMDS40

  • Bare-metal aortic stent
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