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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
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
"One box of RHA® 3 Mepi contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (27G 1/2). Box Packaging (ID 07640173236108) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® 3 Mepi - TSK - US
In Commercial Distribution

  • 07640173236108 ()
  • 07640173236177 ()
940195

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
"One box of RHA® 4 contains two blisters and one instruction for use. Each blister contains a 1,2mL prefilled syringe and two needles (27G 1/2). Box Packaging (ID 07640173234371) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® 4 US 1.2ml Schott/2 aig. TSK 27G1/2
In Commercial Distribution

  • 07640173234388 ()
940083/03

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
"One box of RHA® 3 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (27G 1/2). Box Packaging (ID 07640173234159) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® 3 US 1ml Schott/2 aig. TSK 27G1/2
In Commercial Distribution

  • 07640173234241 ()
940008/03

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
"One box of RHA® 2 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (30G 1/2). Box Packaging (ID 07640173234227) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® 2 US 1ml Schott/2 aig. TSK 30G1/2
In Commercial Distribution

  • 07640173234234 ()
940007/03

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
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