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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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The Oracle EUS latex balloon is intended to be used in endoscopic procedures that utilize a balloon in conjunction with an echoendoscope in the Upper and lower gastrointestinal tract.
US Endoscopy
00711893
Not in Commercial Distribution

  • 10816765013455 ()
  • 00816765013458 ()
00711893

  • Ultrasound endoscope balloon, Hevea-latex
CellSTACK 10-Layer TCT w 40 in .25 ID .375 OD tubing with filter Vent and 40 in tubing 40 in .25 ID .375 OD tubing with plug cap fill
Corning Incorporated
11833
In Commercial Distribution

  • H108118333 ()
  • H108118331 ()
11833

  • Blood/tissue storage/culture container
CellSTACK 5-Layer TCT w 40 in .25 ID .375 OD tubing with filter Vent and 40 in tubing 40 in .25 ID .375 OD tubing with plug cap fill
Corning Incorporated
11832
In Commercial Distribution

  • H108118323 ()
  • H108118321 ()
11832

  • Blood/tissue storage/culture container
CellSTACK 2-Layer TCT w 40 in .25 ID.375 OD tubing with filter Vent and 40 in tubing 40 in .25 ID .375 OD tubing with plug cap fill
Corning Incorporated
11831
In Commercial Distribution

  • H108118313 ()
  • H108118311 ()
11831

  • Blood/tissue storage/culture container
The Oracle EUS latex balloon is intended to be used in endoscopic procedures that utilize a balloon in conjunction with an echoendoscope in the Upper and lower gastrointestinal tract.
US Endoscopy
00711893
In Commercial Distribution

  • 10724995184121 ()
  • 00724995184124 ()
  • 00816765013458 ()
00711893

  • Ultrasound endoscope balloon, Hevea-latex
EpiDisc Otologic Lamina is used as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures.
Anika Therapeutics, Inc.
653-300
Not in Commercial Distribution

1417100

  • Tympanic membrane prosthesis
EpiDisc Otologic Lamina is used as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures.
Anika Therapeutics, Inc.
653-300
Not in Commercial Distribution

  • 08033549790981 ()
1417100

  • Tympanic membrane prosthesis
EpiDisc Otologic Lamina is used as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures.
Anika Therapeutics, Inc.
653-300
Not in Commercial Distribution

  • 08033549790745 ()
1417100

  • Tympanic membrane prosthesis
Antibacterial Sheer Adhesive Bandages; Helps Prevent Infection; Blends with Skin; Highly Absorbent Non-Stick Pad; Long Lasting; Sterile Bandages; Active Ingredient: Benzalkonium Chloride 0.1 percent; Assorted Sizes; 10 - 1 IN. x 3 IN.; 10 - Fingerband 3/4 IN. x 3 IN.
Cardinal Health 110, Inc.
4903167
In Commercial Distribution

  • 50096295124113 ()
  • 00096295124118 ()
  • 10096295124115 ()
4903167

  • Skin-cover adhesive strip, antimicrobial
The Delivery Tip system consists of a static mixer with an attached 22G blunt needle and with an additional unattached 18G blunt needle. The device is provided sterile and intended for single-use only by Rx. The Delivery Tip is indicated for use with the Dual Applicator in the allay™ Nerve Cap (TL-5515-1 and TL-5515-2) system only. The Delivery Tip is not designed, sold, or intended for use except as described by the Indication for Use.
Tulavi Therapeutics, Inc.
TL-7627
In Commercial Distribution

  • 10860012518125 ()
  • 00860012518128 ()
TL-7627

  • Nerve cap delivery mixer/needle
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