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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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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 1.0 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
40144
In Commercial Distribution

  • 10669808003025 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
Revanesse Versa+ with Lidocaine (0.3% w/w) is manufactured by Prollenium Medical Technologies, and is a biocompatible, sterile, injectable hydrogel based on bioresorbable cross-linked hyaluronan (HA) (22 – 28 mg / mL concentration). The gel is delivered in a pre-filled disposable glass syringe. Each box of Revanesse Versa+ with Lidocaine contains two 1.2 mL syringes of Revanesse Versa+ with Lidocaine along with two sterile needles. Revanesse Versa+ with Lidocaine is injected by qualified, trained doctors into the dermis of patients, using a variety of techniques. The injections place a small portion of the gel beneath a crease or wrinkle in the skin and the augmentation of the tissue produces a smoothing effect on the surface.
Prollenium Medical
40083
In Commercial Distribution

  • 10669808001038 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
Revanesse Versa+ with Lidocaine (0.3% w/w) is manufactured by Prollenium Medical Technologies, and is a biocompatible, sterile, injectable hydrogel based on bioresorbable cross-linked hyaluronan (HA) (22 – 28 mg / mL concentration). The gel is delivered in a pre-filled disposable glass syringe. Each box of Revanesse Versa+ with Lidocaine contains two 1.0 mL syringes of Revanesse Versa+ with Lidocaine along with two sterile needles. Revanesse Versa+ with Lidocaine is injected by qualified, trained doctors into the dermis of patients, using a variety of techniques. The injections place a small portion of the gel beneath a crease or wrinkle in the skin and the augmentation of the tissue produces a smoothing effect on the surface.
Prollenium Medical
40082
In Commercial Distribution

  • 10669808001014 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
24 sets per box
BELMONT INSTRUMENT CORPORATION
905-00010
In Commercial Distribution

  • 10896128002098 ()


  • Conduction blood/fluid warmer set
EOlife device (ref: AUS00055) is the sale reference of final medical device including : - EOlife ECU (ref: AUS00004) - EOlife BP (ref: A0000023) - EOlife Charger (ref: A0000063) - EOlife IFU (ref: AUS00057)
ARCHEON
AUS00055
In Commercial Distribution

  • 13770016085066 ()


  • Pulmonary resuscitator, manual, reusable
Radiesse (+) Lidocaine 1.5cc Injectable Implant is a volumizing filler with integral lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (2) 1.5cc Injectable Implant and (4) 27 gauge thin walled x 0.75" needles.
MERZ NORTH AMERICA, INC.
8063M0K2
In Commercial Distribution

  • M2138063M0K25 ()
  • M2138063M0K22 ()

  • Total Volume: 3.0 Milliliter


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
No Description
ICU MEDICAL, INC.
H4026S
In Commercial Distribution

  • 35019315077610 ()
  • 15019315077616 ()
  • 55019315077614 ()


  • Pulmonary resuscitator, manual, single-use
No Description
ICU MEDICAL, INC.
H4025S
In Commercial Distribution

  • 55019315077607 ()
  • 35019315077603 ()
  • 15019315077609 ()


  • Pulmonary resuscitator, manual, single-use
No Description
ICU MEDICAL, INC.
H4024S
In Commercial Distribution

  • 35019315077597 ()
  • 15019315077593 ()
  • 55019315077591 ()


  • Pulmonary resuscitator, manual, single-use
No Description
ICU MEDICAL, INC.
H4022S
In Commercial Distribution

  • 35019315077580 ()
  • 15019315077586 ()
  • 55019315077584 ()


  • Pulmonary resuscitator, manual, single-use
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