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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 T2Candida component that contains the refrigerated reagents used to perform the T2Candida panel.
T2 BIOSYSTEMS, INC.
80-01689
In Commercial Distribution

  • M70880016893 ()
  • M70880009660 ()


  • Multiple Candida species nucleic acid IVD, reagent
Titanium alloy posts are used to affix the proximal end of the plate to the proximal end of the humerus. With the aid of fixtures, the posts have the ability to have cross elements inserted perpendicular to the axis of the cortical thread of the post. The head of the post is a threaded locking configuration that accepts an expansion cap screw. The posts are 5.25mm in diameter and are available in 5 lengths ranging from 30mm to 50mm.
TOBY ORTHOPAEDICS
NA
In Commercial Distribution

  • 00816101010479 ()
TO-52-P-30

  • Orthopaedic bone screw (non-sliding)
Titanium alloy posts are used to affix the proximal end of the plate to the proximal end of the humerus. With the aid of fixtures, the posts have the ability to have cross elements inserted perpendicular to the axis of the cortical thread of the post. The head of the post is a threaded locking configuration that accepts an expansion cap screw. The posts are 5.25mm in diameter and are available in 5 lengths ranging from 30mm to 50mm.
TOBY ORTHOPAEDICS
NA
In Commercial Distribution

  • 00816101010233 ()
TO-52-P-50

  • Orthopaedic bone screw (non-sliding)
Titanium alloy posts are used to affix the proximal end of the plate to the proximal end of the humerus. With the aid of fixtures, the posts have the ability to have cross elements inserted perpendicular to the axis of the cortical thread of the post. The head of the post is a threaded locking configuration that accepts an expansion cap screw. The posts are 5.25mm in diameter and are available in 5 lengths ranging from 30mm to 50mm.
TOBY ORTHOPAEDICS
NA
In Commercial Distribution

  • 00816101010226 ()
TO-52-P-45

  • Orthopaedic bone screw (non-sliding)
Titanium alloy posts are used to affix the proximal end of the plate to the proximal end of the humerus. With the aid of fixtures, the posts have the ability to have cross elements inserted perpendicular to the axis of the cortical thread of the post. The head of the post is a threaded locking configuration that accepts an expansion cap screw. The posts are 5.25mm in diameter and are available in 5 lengths ranging from 30mm to 50mm.
TOBY ORTHOPAEDICS
NA
In Commercial Distribution

  • 00816101010219 ()
TO-52-P-40

  • Orthopaedic bone screw (non-sliding)
Titanium alloy posts are used to affix the proximal end of the plate to the proximal end of the humerus. With the aid of fixtures, the posts have the ability to have cross elements inserted perpendicular to the axis of the cortical thread of the post. The head of the post is a threaded locking configuration that accepts an expansion cap screw. The posts are 5.25mm in diameter and are available in 5 lengths ranging from 30mm to 50mm.
TOBY ORTHOPAEDICS
NA
In Commercial Distribution

  • 00816101010202 ()
TO-52-P-35

  • Orthopaedic bone screw (non-sliding)
The TrueLabor's Monitor Adapter for the hospital maternal/fetal monitoring system. The corresponding Maternal Unit transmits the uterine activity/fetal heart rate information via Bluetooth to the MONITOR ADAPTER which transfers it to the hospital monitor or directly to the hospital IT system.
O.B - TOOLS LTD
FG0002(X)
In Commercial Distribution

  • 07290016406023 ()

  • Depth: 30 Millimeter
  • Width: 200 Millimeter
  • Height: 120 Millimeter
  • Weight: 400 Gram
FG0002(X)

  • Cardiotocography telemetric monitoring system
The Inspire® Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG).
Inspire Medical Systems, Inc.
900-013-001
In Commercial Distribution

  • 00855728005796 ()
4340

  • Implantable sleep apnoea treatment system, respiration-sensing
The Inspire® Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG).
Inspire Medical Systems, Inc.
900-013-003
In Commercial Distribution

  • 10810098650295 ()
4340

  • Implantable sleep apnoea treatment system, respiration-sensing
Inject into the knee to relieve the pain caused by osteoarthritis.
ACRE PHARMA LIMITED
NA
In Commercial Distribution

  • 05060604130010 ()


  • Synovial fluid supplementation medium
Tool used to remove or install the valve in the socket
CYPRESS ADAPTIVE, LLC
CA100-K
In Commercial Distribution

  • 00850013242702 ()
CA100-K

  • External lower-limb prosthesis suspensory component, non-powered
Allow connection of the single use sensor to the Panel PC.
EVENTUM ORTHOPAEDICS LTD
CA001
In Commercial Distribution

  • 05065012584233 ()


  • Electrical-only medical device connection cable, reusable
Trial used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL43550
In Commercial Distribution

  • M269TRL435501 ()
  • 10381780236498 ()

  • Size 50; .659 in dia
TRL-435-50

  • Carpometacarpal interpositional spacer prosthesis trial
Trial used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL43540
In Commercial Distribution

  • M269TRL435401 ()
  • 10381780236481 ()

  • Size 40; .589 in dia
TRL-435-40

  • Carpometacarpal interpositional spacer prosthesis trial
Trial used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL43530
In Commercial Distribution

  • M269TRL435301 ()
  • 10381780236474 ()

  • Size 30; .521 in dia
TRL-435-30

  • Carpometacarpal interpositional spacer prosthesis trial
Trial used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL43520
In Commercial Distribution

  • M269TRL435201 ()
  • 10381780236467 ()

  • Size 20; .457 in dia
TRL-435-20

  • Carpometacarpal interpositional spacer prosthesis trial
Trial used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL43510
In Commercial Distribution

  • M269TRL435101 ()
  • 10381780236450 ()

  • Size 10; .403 in dia
TRL-435-10

  • Carpometacarpal interpositional spacer prosthesis trial
The trocar awl is used to prepare the bone for drilling.
NEWDEAL
519040ND
In Commercial Distribution

  • M248519040ND1 ()
  • 10381780051466 ()

  • 4.3mm diameter X 200mm total length


  • Bone awl, reusable
Accessory items used to support the use of the PSCS device.
PAXMAN COOLERS LIMITED
Accessories Pack
Not in Commercial Distribution

  • B561ACCESSORIES2 ()
Accessories Pack

  • Scalp cooling system, hair loss
BPM-337 ables to measure the blood pressure and the heart rate
Sevenground Trading B.V.
BPM-337
In Commercial Distribution

  • 08719699633469 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
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