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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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No Description
EAGLE SPRINGS ENTERPRISES LLC
NA
Not in Commercial Distribution

  • 00866394000206 ()


  • Synovial fluid supplementation medium
An implantable arc designed to flatten the anterior corneal curvature, without disturbing the visual axis, to correct certain corneal-related visual disorders. The medical device is a plastic arc, of about 150 degrees, that is inserted into the cornea via an intrastromal channel. It is typically available in sizes from 0.250 to 0.450 mm.
ADDITION TECHNOLOGY, INC.
ICI
In Commercial Distribution

  • 00866304000104 ()


  • Intracorneal ring segment
  • Intracorneal ring
No Description
Hancock Jaffe Laboratories, Inc.
HJL016-40-N
In Commercial Distribution

  • 00866271000039 ()

  • Length: 40 Centimeter
  • Lumen/Inner Diameter: 6 Millimeter


  • Arteriovenous shunt
No Description
Hancock Jaffe Laboratories, Inc.
HJL016-30-N
In Commercial Distribution

  • 00866271000022 ()

  • Length: 30 Centimeter
  • Lumen/Inner Diameter: 6 Millimeter


  • Arteriovenous shunt
No Description
Hancock Jaffe Laboratories, Inc.
HJL016-25-N
In Commercial Distribution

  • 00866271000015 ()

  • Length: 25 Centimeter
  • Lumen/Inner Diameter: 6 Millimeter


  • Arteriovenous shunt
No Description
Hancock Jaffe Laboratories, Inc.
HJL016-10-N
In Commercial Distribution

  • 00866271000008 ()

  • Length: 10 Centimeter
  • Lumen/Inner Diameter: 6 Millimeter


  • Arteriovenous shunt
Cross-Linked Hyaluronic Acid and Lidocaine Injectable Gel
Anika Therapeutics, Inc.
685-310
Not in Commercial Distribution

  • 00866142000014 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
Cross-Linked Hyaluronic Acid and Lidocaine Injectable Gel
Anika Therapeutics, Inc.
685-015
In Commercial Distribution

  • 00866142000007 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
Perotineal Dialysis Transfer Catheter
PURACATH MEDICAL, INC
40398
Not in Commercial Distribution

  • 00865349000315 ()
  • 00865349000322 ()


  • Peritoneal dialysis catheter, chronic
1.25cc Paste Mix Plus
ISTO TECHNOLOGIES INC
IN012
In Commercial Distribution

  • 00865179000073 ()
IQSP-PP-101

  • Synthetic bone graft
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