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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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Endocervical curette system for tissue collection, storage, and transport.
HISTOLOGICS, LLC
SFT-2000
In Commercial Distribution

  • 10860275000320 ()
  • 00860275000323 ()
SFT-2000

  • Endocervical specimen collection kit
Supporting infection control, TwitchView™ utilizes a single-patient use Electrode Array. With the flexibility to secure to either left or right hand in seconds, the Electrode Array is easily adopted into the pre-surgical workflow. The one-piece, auto-centering design mitigates placement errors—a common cause of intra-operative system failure and measurement inaccuracies.
BLINK DEVICE COMPANY
Electrode v1
In Commercial Distribution

  • 00860298001086 ()
  • 00860298001055 ()


  • Neuromuscular transmission electrode
PTFE Non-absorbable Suture 18 inch in length, USP 6/0, Reverse Cutting Needle, 13mm, 3/8 curvature, Sterile
Golnit Sutures
mRD601338-45
In Commercial Distribution

  • 00860293000664 ()
  • 00860000584029 ()

  • 13mm 3/8 Circle Reverse Cutting Needle
  • USP 6/0 Suture Thread
  • Length: 18 Inch


  • Polytetrafluoroethylene suture
Stimulator, nerve, transcutaneous, for pain relief. The ReBuilder is an intelligent medical device that relieves chronic pain by calming erratic nerve signals, strengthening muscles, and restoring local blood flow.
REBUILDER MEDICAL INC.
2407
In Commercial Distribution

  • 00866650000308 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered
Foot examination tool for inflammatory changes.
Podimetrics, Inc.
PMHS201U-R
In Commercial Distribution

  • 00866538000314 ()
PMHS201U-R

  • Temperature telemetric monitoring system
Foot examination tool for inflammatory changes.
Podimetrics, Inc.
PMHS201U
In Commercial Distribution

  • 00866538000307 ()
PMHS201U

  • Temperature telemetric monitoring system
The Procleix Xpress System v3.2 (Software and Instrument) is intended to be used to create whole blood lysates and pools of whole blood lysate for blood screening tests for nucleic acids. The Procleix Xpress System automatically creates the lysate by adding whole blood to a lysis buffer. The resulting lysates may then be transferred into a single master pool tube. The pooled or individual lysates may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes and racks used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 3.2
In Commercial Distribution

  • 00866489000098 ()
741743

  • Nucleic acid sample preparation instrument IVD, semi-automated
The Procleix Xpress® System v2.0 (Software and instrument) is intended to be used to create whole blood lysates and pools of whole blood lysates for blood screening tests for nucleic acids. The Procleix Xpress System automatically creates the lysate by adding whole blood to a lysis buffer. The resulting lysates may then be transferred into a single master pool tube. The pooled or individual lysates may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes and racks used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 2.0
In Commercial Distribution

  • 00866489000029 ()
740807

  • Pipetting system
The Cassi Rotational Core Biopsy System with Quadpoint Disposable is used to perform biopsy pro-cedures on multiple patients. Up to 7 biopsy cycles (1 mandatory pre-test and 6 biopsies) can be performed per patient. The Cassi system components and catalog numbers are: REF: CS2100-NT Cassi Rotational Core Biopsy Needle – 10 gauge 10 – Sterile single-use biopsy needles and sample trays; comprised of a 19 gauge x 2 cm length securing needle with 10 gauge cutting cannula with trocar REF: CS2120-NT Cassi Rotational Core Biopsy Needle – 12 gauge 10 – Sterile single-use biopsy needles and sample trays; comprised of a 19 gauge x 2 cm length securing needle with a 12 gauge cutting cannula with trocar REF: CS2001-CC-10 10 – Non-sterile single-use CO2 (carbon dioxide) canisters with caps REF:CS2001-BH 1 – Non-sterile limited reusable biopsy handle and 1 spare limited-use 9 – volt alkaline battery
SCION MEDICAL TECHOLOGIES, LLC
CS-2001-CC-10
In Commercial Distribution

  • 00866479000152 ()


  • Soft-tissue biopsy needle, single-use
The Cassi Rotational Core Biopsy System with Quadpoint Disposable is used to perform biopsy pro-cedures on multiple patients. Up to 7 biopsy cycles (1 mandatory pre-test and 6 biopsies) can be performed per patient. The Cassi system components and catalog numbers are: REF: CS2100-NT Cassi Rotational Core Biopsy Needle – 10 gauge 10 – Sterile single-use biopsy needles and sample trays; comprised of a 19 gauge x 2 cm length securing needle with 10 gauge cutting cannula with trocar REF: CS2120-NT Cassi Rotational Core Biopsy Needle – 12 gauge 10 – Sterile single-use biopsy needles and sample trays; comprised of a 19 gauge x 2 cm length securing needle with a 12 gauge cutting cannula with trocar REF: CS2001-CC-10 10 – Non-sterile single-use CO2 (carbon dioxide) canisters with caps REF:CS2001-BH 1 – Non-sterile limited reusable biopsy handle and 1 spare limited-use 9 – volt alkaline battery
SCION MEDICAL TECHOLOGIES, LLC
CS2120-NT-1
In Commercial Distribution

  • 10866479000135 ()
  • 00866479000138 ()


  • Soft-tissue biopsy needle, single-use
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