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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 BL-Cart™ IOL Delivery Cartridge is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through a surgical procedure. The cartridge is intended to be used in conjunction with Alcon Monarch® III IOL Delivery System injector. The BL-Cart™ IOL Delivery Cartridge is only for the insertion of Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the approved IOL labeling.
AST PRODUCTS, INC.
Type D
In Commercial Distribution

  • 10814899027065 ()
  • 00814899027068 ()


  • Intraocular lens-insertion cartridge
The FloPump 57mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or ii) Temporary circulatory bypass for diversion offlow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
Movair, Inc.
6500S
Not in Commercial Distribution

  • 00814321020438 ()
6500S

  • Cardiopulmonary bypass system centrifugal pump
The FloPump 32mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or ii) Temporary circulatory bypass for diversion offlow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
Movair, Inc.
6400S
Not in Commercial Distribution

  • 00814321020131 ()
6400S

  • Cardiopulmonary bypass system centrifugal pump
NuForra Surgical Wound Care consists of fibrous, Type I bovine collagen intended for the management of surgical wounds and a wide range of acute and chronic wounds. NuForra is designed to support a moist wound environment to promote natural healing. Indications for Use: Indicated for surgical wounds, partial- and full-thickness wounds, pressure ulcers (Stages I-IV), venous ulcers, ulcers caused by mixed vascular etiologies, venous stasis ulcers, diabetic ulcers, first- and second-degree burns, cuts, and abrasions. NuForra is suitable for application to surgical incision sites and wounds.
KAIROS BIOSCIENCES LLC
NUF-300
In Commercial Distribution

  • 00198715991772 ()


  • Exudate-absorbent dressing, non-gel, antimicrobial
Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Regenomer® is manufactured in three types, Regenomer® Syringe (sheet shape in syringe and blister), Regenomer® Plug (bullet shape in blister), and Regenomer® Block (block shape in blister). Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSP1-S
In Commercial Distribution

  • 08809186549448 ()

  • 8mm X 18mm


  • Dental bone matrix implant, animal-derived
Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Regenomer® is manufactured in three types, Regenomer® Syringe (sheet shape in syringe and blister), Regenomer® Plug (bullet shape in blister), and Regenomer® Block (block shape in blister). Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSB1-S
In Commercial Distribution

  • 08809186549424 ()

  • 6mm X 5mm X 7mm


  • Dental bone matrix implant, animal-derived
Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Regenomer® is manufactured in three types, Regenomer® Syringe (sheet shape in syringe and blister), Regenomer® Plug (bullet shape in blister), and Regenomer® Block (block shape in blister). Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSP2-L
In Commercial Distribution

  • 08809186549455 ()

  • 12mm X 25mm


  • Dental bone matrix implant, animal-derived
Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Regenomer® is manufactured in three types, Regenomer® Syringe (sheet shape in syringe and blister), Regenomer® Plug (bullet shape in blister), and Regenomer® Block (block shape in blister). Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSB2-L
In Commercial Distribution

  • 08809186549431 ()

  • 8mm X 7mm X 9mm


  • Dental bone matrix implant, animal-derived
BIOPAD® is a wound dressing for topical use to control minor bleedings and for the management of any kind of ulcer and skin lesion to help wound closure. BIOPAD® is a sponge-shaped device, constituted exclusively by lyophilized type I native heterologous collagen extracted from horse flexor tendon. When applied to a wound, BIOPAD® constitutes a barrier for the wound against exogenous infective agents. BIOPAD® is the ideal first-aid means to control minor bleeding. The device may be used by healthcare professionals. BIOPAD® is supplied sterile and for one-time use only.
EURORESEARCH SRL
4x4
In Commercial Distribution

  • 08054953400112 ()


  • Animal-derived wound matrix dressing
BIOPAD® is a wound dressing for topical use to control minor bleedings and for the management of any kind of ulcer and skin lesion to help wound closure. BIOPAD® is a sponge-shaped device, constituted exclusively by lyophilized type I native heterologous collagen extracted from horse flexor tendon. When applied to a wound, BIOPAD® constitutes a barrier for the wound against exogenous infective agents. BIOPAD® is the ideal first-aid means to control minor bleeding. The device may be used by healthcare professionals. BIOPAD® is supplied sterile and for one-time use only.
EURORESEARCH SRL
2x2
In Commercial Distribution

  • 08054953400105 ()


  • Animal-derived wound matrix dressing
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