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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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SIENTRA Anatomical Controlled Tissue Expander (ACX) - 00812790022076

Anatomical Controlled Tissue Expander, Moderate Height, ACX, 340 cc
Sientra, Inc.
20719-340ACX
Not in Commercial Distribution

  • 00812790022076 ()

  • Volume: 340 cc
20719-340ACX

  • Skin-port tissue expander

SIENTRA Anatomical Controlled Tissue Expander (ACX) - 00812790022069

Anatomical Controlled Tissue Expander, Moderate Height, ACX, 250 cc
Sientra, Inc.
20719-250ACX
Not in Commercial Distribution

  • 00812790022069 ()

  • Volume: 250 cc
20719-250ACX

  • Skin-port tissue expander

SIENTRA Anatomical Controlled Tissue Expander (ACX) - 00812790022052

Anatomical Controlled Tissue Expander, Moderate Height, ACX, 180 cc
Sientra, Inc.
20719-180ACX
Not in Commercial Distribution

  • 00812790022052 ()

  • Volume: 180 cc
20719-180ACX

  • Skin-port tissue expander

CUSA® NXT - 10381780040293

CUSA® NXT Selector Tubing
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1517079
Not in Commercial Distribution

  • 30381780040297 ()
  • 10381780040293 ()
  • M26915170791 ()
1517079

  • Surgical irrigation/aspiration tubing set

CUSA® NXT - 10381780040255

MRI Tubing Kit Extension:The Selector tubing connects the handpiece to the IV fluid and connects the handpiece to the suction canister on the CUSA® Selector / CUSA NXT console.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1532024
Not in Commercial Distribution

  • 30381780040259 ()
  • 10381780040255 ()
  • M26915320241 ()


  • Surgical irrigation/aspiration tubing set

CUSA® Excel - 10381780039549

CUSA® Excel Reusable Nosecone 36kHz
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C223600215
In Commercial Distribution

  • M273C2236002151 ()
  • 10381780039549 ()

  • 36kHz Ultrasonic Frequency
C223600215

  • Soft-tissue ultrasonic surgical system handpiece, reusable

3D Dental- Bioviva - 00817169021964

Bioviva Soluble Dental Hemostatic Gauze
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
BHG
In Commercial Distribution

  • 00817169021964 ()


  • General oral wound dressing, non-animal-derived, sterile

CUSA® Selector® - 10381780040712

Neurosurgical Long Extension Shroud: The shrouds are intended to direct the saline irrigation fluid to the site of operation. Shroud Black heat resistant shrouds that are interconnected by snap-in push fittings with the exception of the laparoscopic handpiece which has a screw thread joint. The shrouds cover one or two titanium alloy parts. All handpieces contain a tip. Angled handpieces also include an angled extension.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523045
Not in Commercial Distribution

  • 10381780040712 ()
  • 00381780040715 ()

  • 24kHz Ultrasonic Frequency


  • Soft-tissue ultrasonic surgical system handpiece, reusable

CUSA® NXT - 10381780039501

The CUSA NXT Extended Length Tip for soft tissue is an accessory to the CUSA NXT and CUSA Selector Ultrasonic Surgical Aspirator Systems that are indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, including Neurosurgery/Gastrointestinal and affiliated organ surgery/Urological surgery/Plastic and Reconstructive surgery/General surgery/Orthopedic surgery/Gynecological surgery/Thoracic surgery/Laparoscopic surgery/Thoracoscopic surgery.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523243
Not in Commercial Distribution

  • M610152324315 ()
  • 10381780039501 ()
  • 00381780039504 ()

  • 35kHz Ultrasonic Frequency


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use

CUSA® NXT - 10381780039488

The CUSA NXT Bone Tips are accessories to the CUSA NXT Ultrasonic Surgical Aspirator System that is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
NXT3220
Not in Commercial Distribution

  • 30381780039482 ()
  • 10381780039488 ()
  • M269NXT322011 ()


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
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