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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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Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. The device is a kitted pack containing: (1) a pre-filled, sterile Belotero Balance (+) Lidocaine gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2, 30G x 1/2), and (3) two patient record labels
ANTEIS SA
8710M0S
In Commercial Distribution

  • 07640123791343 ()

  • Total Volume: 1.0 Milliliter
  • Needle Gauge: 27 Gauge
  • Needle Gauge: 30 Gauge


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. The device is a kitted pack containing: (1) a pre-filled, sterile Belotero Balance (+) Lidocaine gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2, 30G x 1/2), and (3) two patient record labels
ANTEIS SA
8705M0S
In Commercial Distribution

  • 07640123791220 ()

  • Total Volume: 1.0 Milliliter
  • Needle Gauge: 27 Gauge
  • Needle Gauge: 30 Gauge


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. The device is a kitted pack containing: (1) a pre-filled, sterile Belotero Balance gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2 in, 30G x 1/2 in), and (3) two patient record labels.
ANTEIS SA
8700M0S
In Commercial Distribution

  • 07640123791213 ()

  • Needle Gauge: 27 Gauge
  • Needle Gauge: 30 Gauge
  • Total Volume: 1 Milliliter


  • Dermal tissue reconstructive material, microbe-derived
Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. The device is a kitted pack containing: (1) a pre-filled, sterile Belotero Balance gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2 in, 30G x 1/2 in), and (3) two patient record labels.
ANTEIS SA
8706M0
In Commercial Distribution

  • 07640123791152 ()

  • Total Volume: 1 Milliliter
  • Needle Gauge: 27 Gauge
  • Needle Gauge: 30 Gauge


  • Dermal tissue reconstructive material, microbe-derived
Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. The device is a kitted pack containing: (1) a pre-filled, sterile Belotero Balance (+) Lidocaine gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2, 30G x 1/2), and (3) two patient record labels
ANTEIS SA
8710M0
In Commercial Distribution

  • 07640123791145 ()

  • Total Volume: 1.0 Milliliter
  • Needle Gauge: 27 Gauge
  • Needle Gauge: 30 Gauge


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. The device is a kitted pack containing: (1) a pre-filled, sterile Belotero Balance (+) Lidocaine gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2, 30G x 1/2), and (3) two patient record labels
ANTEIS SA
8705M0
In Commercial Distribution

  • 07640123791138 ()

  • Total Volume: 1.0 Milliliter
  • Needle Gauge: 27 Gauge
  • Needle Gauge: 30 Gauge


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. The device is a kitted pack containing: (1) a pre-filled, sterile Belotero Balance gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2 in, 30G x 1/2 in), and (3) two patient record labels.
ANTEIS SA
8700M0
In Commercial Distribution

  • 07640123791121 ()

  • Total Volume: 1 Milliliter
  • Needle Gauge: 27 Gauge
  • Needle Gauge: 30 Gauge


  • Dermal tissue reconstructive material, microbe-derived
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
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
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