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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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The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
OT EQUATOR Flat One Gold & Blu h.3
In Commercial Distribution

  • 08059224123493 ()
030ILG3

  • Dental implant suprastructure, permanent, preformed
T5 cm 6,5x10 is a semirigid pre-shaped mesh with eccentric hole knitted with Polypropylene monofilament, indicated for use in inguinal hernia repairs when there is a significant destruction or weakness of the posterior wall.
HERNIAMESH SRL
PT50-S
Not in Commercial Distribution

  • 58032919891193 ()
  • 18032919891195 ()


  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Nerbridge® is a product composed of polyglycolic acid and collagen derived from porcine skin. Nerbridge® is a flexible, resorbable and semipermeable tubular membrane matrix filled with porous collagen that provides a non-constricting encasement for injured peripheral nerves for protection of the neural environment. Nerbridge® is designed to be an interface between the nerve and the surrounding tissue. When hydrated, Nerbridge® is an easy to handle, pliable, soft, non-friable, porous conduit. The resilience of Nerbridge® allows the product to recover and maintain closure without constricting the nerve once the device is placed around the nerve. Nerbridge® is manufactured using validated viral inactivation and removal processes for the collagen. The product is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, and in double peel packages.
TOYOBO CO., LTD.
RN01525E
Not in Commercial Distribution

  • 04965838907418 ()

  • Inner diameter: 1.5mm and Length: 25mm
RN01525E

  • Nerve guide, animal-derived
Nerbridge® is a product composed of polyglycolic acid and collagen derived from porcine skin. Nerbridge® is a flexible, resorbable and semipermeable tubular membrane matrix filled with porous collagen that provides a non-constricting encasement for injured peripheral nerves for protection of the neural environment. Nerbridge® is designed to be an interface between the nerve and the surrounding tissue. When hydrated, Nerbridge® is an easy to handle, pliable, soft, non-friable, porous conduit. The resilience of Nerbridge® allows the product to recover and maintain closure without constricting the nerve once the device is placed around the nerve. Nerbridge® is manufactured using validated viral inactivation and removal processes for the collagen. The product is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, and in double peel packages.
TOYOBO CO., LTD.
RN03025E
Not in Commercial Distribution

  • 04965838907449 ()

  • Inner diameter: 3.0mm and Length: 25mm
RN03025E

  • Nerve guide, animal-derived
Nerbridge® is a product composed of polyglycolic acid and collagen derived from porcine skin. Nerbridge® is a flexible, resorbable and semipermeable tubular membrane matrix filled with porous collagen that provides a non-constricting encasement for injured peripheral nerves for protection of the neural environment. Nerbridge® is designed to be an interface between the nerve and the surrounding tissue. When hydrated, Nerbridge® is an easy to handle, pliable, soft, non-friable, porous conduit. The resilience of Nerbridge® allows the product to recover and maintain closure without constricting the nerve once the device is placed around the nerve. Nerbridge® is manufactured using validated viral inactivation and removal processes for the collagen. The product is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, and in double peel packages.
TOYOBO CO., LTD.
RN02025E
Not in Commercial Distribution

  • 04965838907425 ()

  • Inner diameter: 2.0mm and Length: 25mm
RN02025E

  • Nerve guide, animal-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
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
AS-SBXM1606POS
In Commercial Distribution

  • 05712821011282 ()
AS-SBXM1606POS

  • Dental prosthesis/implant abutment screw
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
AS-NGMM1610POS
In Commercial Distribution

  • 05712821010513 ()
AS-NGMM1610POS

  • Dental prosthesis/implant abutment screw
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
AS-HETM2008POS
In Commercial Distribution

  • 05712821010506 ()
AS-HETM2008POS

  • Dental prosthesis/implant abutment screw
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