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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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128 in. (320 cm) Microset - Blue Stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-125XSE
Not in Commercial Distribution

  • 10818666020266 ()
  • 00818666020269 ()


  • Electric infusion pump administration set, single-use
83 in. (210 cm) Microset - Blue Stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-003XSNY
Not in Commercial Distribution

  • 10818666020167 ()
  • 00818666020160 ()


  • Electric infusion pump administration set, single-use
150 in. (380 cm) For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-003XYVA
Not in Commercial Distribution

  • 10818666020143 ()
  • 00818666020146 ()


  • Electric infusion pump administration set, single-use
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
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
3cm Guided Coagulation System Kit
ATRICURE, INC.
CDK-1413
In Commercial Distribution

  • 00818354015249 ()

  • Length: 3 Centimeter


  • Cardiac radio-frequency ablation system generator
1cm Guided Coagulation System Kit
ATRICURE, INC.
CDK-1411
In Commercial Distribution

  • 00818354015201 ()

  • Length: 1 Centimeter


  • Cardiac radio-frequency ablation system generator
RF Coagulation Cable Kit
ATRICURE, INC.
CSK-2000
In Commercial Distribution

  • 00818354015300 ()


  • Cardiac radio-frequency ablation system generator
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