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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 NovaSure® Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
Hologic, Inc.
V5
In Commercial Distribution

  • 15420045514294 ()
  • 35420045514298 ()
  • 25420045514291 ()
NSV5US-001

  • Radio-frequency endometrial-ablation system handpiece/electrode
Revanesse® Lips+ is manufactured by Prollenium Medical Technologies, and is a biocompatible, biodegradable, non-pyrogenic, sterile, injectable viscoelastic clear colorless hydrogel based on bioresorbable BDDE cross-linked hyaluronan (HA) (22 – 28 mg / mL concentration) containing 0.3% lidocaine. The HA is produced by the Streptococcus species of bacteria. The gel is delivered in a pre-filled disposable glass syringe. Each syringe is fitted with a Luer lock adaptor, a plunger rod, a rubber stopper tip cap, and a finger grip. Each box of Revanesse® Lips+ contains two 1.2 mL syringes of Revanesse® Lips+ along with two 0.5-inch 30-gauge sterile needles. The syringe is labeled with the product name, the manufacturer, lot number, and expiration date. There is a removable portion of the label, which can be affixed to the patient record.
Prollenium Medical
40149
In Commercial Distribution

  • 10669808003032 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
The COSEAL Applicator is used for mixing and delivery of the two COSEAL Surgical Sealant Components.
BAXTER HEALTHCARE CORPORATION
934034
In Commercial Distribution

  • 00085412083339 ()
  • 50085412083334 ()

  • Length: 22 Centimeter
934034

  • Open-surgery adhesive/sealant applicator, dual-channel
The COSEAL Applicator is used for mixing and delivery of the two COSEAL Surgical Sealant Components.
BAXTER HEALTHCARE CORPORATION
934033
In Commercial Distribution

  • 50085412083327 ()
  • 00085412083322 ()

  • Length: 7 Centimeter
  • Height: 7 Centimeter
934033

  • Open-surgery adhesive/sealant applicator, dual-channel
The Prismaflex TPE2000 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered), after having selected TPE therapy. The Prismaflex TPE2000 set is intended for use in therapeutic plasma exchange, thus in diseases where removal of plasma components in indicated.
GAMBRO INDUSTRIES
114093
In Commercial Distribution

  • 07332414111038 ()
  • 37332414111039 ()
114093

  • Apheresis system filter, whole blood
RapidPort® EZ Port Applier Tool
ReShape Lifesciences Inc.
C-20390
In Commercial Distribution

C-20390

  • Infusion/injection port/tack applicator
LAP-BAND® AP Adjustable Gastric Banding System Large with RapidPort EZ
ReShape Lifesciences Inc.
C-2365
In Commercial Distribution


  • Large
C-2365

  • Gastric band
LAP-BAND® AP Adjustable Gastric Banding System Standard with RapidPort EZ
ReShape Lifesciences Inc.
C-2360
In Commercial Distribution


  • Standard
C-2360

  • Gastric band
ReShape Lap-Band® 2.0, FLEX Tubing Kit
ReShape Lifesciences Inc.
D-3500
In Commercial Distribution

  • 00850007764586 ()
D-3500

  • Gastric band repair kit
ReShape Lap-Band® 2.0, FLEX & Access Port, Large
ReShape Lifesciences Inc.
D-3306
In Commercial Distribution

  • 00850007764555 ()

  • Large
D-3306

  • Gastric band access port kit
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