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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 RONDEX CPR VALVE Model #2020 is for emergency used only with a suitable CPR mask to help isolate the patient's breath from the rescuer. . It has a single flapper valve which stays flexible under very cold conditions. Fits masks with 15 mm OD stem or 22 mm ID opening. Made in USA
RONDEX PRODUCTS, INCORPORATED
2020 package in polybag
Not in Commercial Distribution

  • 06343760020203 ()
2020

  • Non-rebreathing valve, single-use
No Description
Biomet Orthopedics, LLC
471316
In Commercial Distribution

  • 00880304382954 ()
471316

  • Surgical instrument handle, non-torque-limiting
BLOOD MANAGEMENT SYSTEM
Edwards Lifesciences LLC
VJL0063
In Commercial Distribution

  • 50690103198237 ()
  • 00690103198232 ()
VJL0063

  • Arterial blood sampling kit
No Description
Biomet Orthopedics, LLC
32-347208
In Commercial Distribution

  • 00880304327818 ()
32-347208

  • Fluted surgical drill bit, reusable
No Description
Biomet Orthopedics, LLC
32-347151
In Commercial Distribution

  • 00880304327764 ()
32-347151

  • Surgical drill guide, reusable
No Description
Biomet Orthopedics, LLC
32-480117
In Commercial Distribution

  • 00880304348448 ()
32-480117

  • Surgical drill guide, reusable
RALLY ALL IN ONE CEMENT GUN is intended to be used for helping the extrusion (and hence the delivery) of the bone cement prepared with the RALLY ALL IN ONE SYSTEM devices.
TECRES SPA
71271610
In Commercial Distribution

  • 08031497002330 ()


  • Orthopaedic cement/bone filler dispensing gun
Brazilian TUV Conversion Kit
Candela Corporation
7122-00-9663
Not in Commercial Distribution

  • 00817495021218 ()


  • Dermatological solid-state laser system
No Description
Zimmer, Inc.
SSI003319
In Commercial Distribution

  • 00889024590007 ()

  • 1/4 Inch
SSI003319

  • Acetabular orthopaedic reamer
The Symblepharon rings are used to prevent retraction of the conjunctiva cul-de-sac. The ring is inserted between the eye and the lid and is supported by the sclera without touching the cornea. The purpose of the Symblepharon Rings is to avoid tissue adhesion after excision of the symblepharon. The ring has a center hole to enable the patient to see. The surfaces are polished in order to avoid any abrasion of the cornea or ocular globe. The Symblepharon Rings are medical devices made of acrylic (PMMA). They must not be autoclaved, otherwise they will be damaged: ethylene oxide sterilization is recommended. The devices' family has different sizes (small, medium, large).
Oculo-Plastik Inc
21-416V
Not in Commercial Distribution

  • M87221416V95 ()

  • Outer Diameter: 24 Millimeter


  • Symblepharon ring, synthetic
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