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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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Life Support Products - 00026072000243

Disp, Bag Mask resus, LSP, Infant, Configuration
Allied Medical, LLC
DS203
In Commercial Distribution

  • 00026072000243 ()
  • 40026072000241 ()
DS203

  • Pulmonary resuscitator, manual, single-use

Life Support Products - 00026072000236

Dis, Bag Mask Resus, LSP, Child Configuration
Allied Medical, LLC
DS202
In Commercial Distribution

  • 00026072000236 ()
  • 40026072000234 ()
DS202

  • Pulmonary resuscitator, manual, single-use

Life Support Products - 00026072000229

Disp Bag Mask Resus, LSP, Adult Configuration
Allied Medical, LLC
DS201
In Commercial Distribution

  • 00026072000229 ()
  • 40026072000227 ()
DS201

  • Pulmonary resuscitator, manual, single-use

Bound Tree - 00026072000212

Disp Bag Mask Resus, Bound Tree, Infant Configuration
Allied Medical, LLC
DS103
In Commercial Distribution

  • 00026072000212 ()
  • 40026072000210 ()
DS103

  • Pulmonary resuscitator, manual, single-use

Bound Tree - 00026072000205

Disp Bag Mask Resus, Bound Tree, Child Configuration
Allied Medical, LLC
DS102
In Commercial Distribution

  • 00026072000205 ()
  • 40026072000203 ()
DS102

  • Pulmonary resuscitator, manual, single-use

Boundtree - 00026072000199

Disp Bag Mask Resus, Bound Tree Adult Configuration
Allied Medical, LLC
DS101
In Commercial Distribution

  • 00026072000199 ()
  • 40026072000197 ()
DS101

  • Pulmonary resuscitator, manual, single-use

Revanesse Lips+ with Lidocaine 1.2 mL - 10669808003032

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+ with Lidocaine 1.0 mL - 10669808003025

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 1.2 mL - 10669808001038

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 1.0 mL - 10669808001014

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
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