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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 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
Neck Trial, Size 24, Lateral, Dual Taper
NEXTSTEP ARTHROPEDIX, LLC
10-81-0424
In Commercial Distribution

  • 00816127028281 ()


  • Femoral stem prosthesis trial
Neck Trial, Size 22, Lateral, Dual Taper
NEXTSTEP ARTHROPEDIX, LLC
10-81-0422
In Commercial Distribution

  • 00816127028274 ()


  • Femoral stem prosthesis trial
Quick Connect Cup Trial Size 66
NEXTSTEP ARTHROPEDIX, LLC
10-84-0066
In Commercial Distribution

  • 00816127021114 ()


  • Acetabulum prosthesis trial, prefabricated, reusable
The device is indicated for extracorporeal shock wave treatment.
Storz Medical AG
Intelect F-SW USA
In Commercial Distribution

  • 07630039101312 ()


  • Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system
No Description
Storz Medical AG
CHATTANOOGA Intelect F-SW USA
In Commercial Distribution

  • 07630039101022 ()


  • Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system
Narrow Glenoid Retractor
Revelation Medical Devices
10-2974
In Commercial Distribution

  • G3181029740 ()
10-2974

  • Hand-held surgical retractor, reusable
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