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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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Orpheus CAST Mobile App Android OS - 07290017025124

A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025124 ()
ML-EG30001

  • Radiology information system application software

Orpheus CAST Mobile App iOS + Android - 07290017025100

A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025100 ()
MLL-EG30001

  • Radiology information system application software

Resilience – By Inner Armor App iOS - 07540191000630

No Description
Thought Technology Ltd.
SA4515
In Commercial Distribution

  • 07540191000630 ()


  • Psychophysiological biofeedback system

Jenx - 05056235203933

Headrest Cover U/W Mh07 Yellow
JENX LIMITED
COVH4-09
In Commercial Distribution

  • 05056235203933 ()


  • Medical cushion cover

Airlife - 10889483057957

AirLife™ U/Adapt-It Straight Adapter
AIRLIFE
004081
In Commercial Distribution

  • 10889483057957 ()
  • 10190752154193 ()
  • 30889483057951 ()
004081

  • Straight/elbow breathing circuit connector, single-use

AirLife™ - 10889483571842

AirLife™ U/Adapt-It Straight Connector
AIRLIFE
004204
In Commercial Distribution

  • 30889483571846 ()
  • 10889483571842 ()
004204

  • Straight/elbow breathing circuit connector, single-use

AirLife™ - 10889483571781

AirLife™ U/Adapt-It Straight Adapter
AIRLIFE
004078
In Commercial Distribution

  • 30889483571785 ()
  • 10889483571781 ()
004078

  • Straight/elbow breathing circuit connector, single-use

Medtronic Reusable Instruments - 00643169212237

AWL TAP EX0512319 4.0MM-4.5MM U JOINT
MEDTRONIC SOFAMOR DANEK, INC.
EX0512319
In Commercial Distribution

  • 00643169212237 ()


  • Bone awl, reusable

Medline - 10193489449662

TTL1LYR 16FR10ML 100%SILI CS U
MEDLINE INDUSTRIES, INC.
URO170816CS
In Commercial Distribution

  • 40193489449663 ()
  • 10193489449662 ()

  • Catheter Gauge: 16 French
URO170816CS

  • Indwelling urethral catheterization kit, adult

Custom Perfusion System - 00613994634757

CUSTOM PACK CB0M94R9 U OF IL
MEDTRONIC, INC.
CB0M94R9
Not in Commercial Distribution

  • 00613994634757 ()


  • Cardiopulmonary bypass system blood tubing set

CARDINAL HEALTH - 10888439507942

CUSTOM G U T S TRAY
Cardinal Health 200, LLC
32-1395C
In Commercial Distribution

  • 50888439507940 ()
  • 10888439507942 ()
32-1395C

  • General surgical procedure kit, medicated

Archwire - D972AMC20UMAREU2

.020 Premium Thermal - NiTi - Euro - U
Acme Monaco Corporation
AMC20UMAREU
In Commercial Distribution

  • D972AMC20UMAREU2 ()
  • AMC20UMAREU0 ()


  • Orthodontic archwire

Archwire - D972AMC20LMAR2

.020 Premium Thermal - NiTi - Nat - U
Acme Monaco Corporation
AMC20LMAR
In Commercial Distribution

  • D972AMC20LMAR2 ()
  • AMC20LMAR0 ()


  • Orthodontic archwire

Archwire - D972AMC2020UMAREU2

20x20 Premium Thermal - NiTi - Euro - U
Acme Monaco Corporation
AMC2020UMAREU
In Commercial Distribution

  • D972AMC2020UMAREU2 ()
  • AMC2020UMAREU0 ()


  • Orthodontic archwire

Archwire - D972AMC2020UMAR2

20x20 Premium Thermal - NiTi - Nat - U
Acme Monaco Corporation
AMC2020UMAR
In Commercial Distribution

  • D972AMC2020UMAR2 ()
  • AMC2020UMAR0 ()


  • Orthodontic archwire

Archwire - D972AMC1925UMAREU2

19x25 Premium Thermal - NiTi - Euro - U
Acme Monaco Corporation
AMC1925UMAREU
In Commercial Distribution

  • D972AMC1925UMAREU2 ()
  • AMC1925UMAREU0 ()


  • Orthodontic archwire

Archwire - D972AMC18UMAREU2

.018 Premium Thermal - NiTi - Euro - U
Acme Monaco Corporation
AMC18UMAREU
In Commercial Distribution

  • D972AMC18UMAREU2 ()
  • AMC18UMAREU0 ()


  • Orthodontic archwire

Archwire - D972AMC18UMAR2

.018 Premium Thermal - NiTi - Nat - U
Acme Monaco Corporation
AMC18UMAR
In Commercial Distribution

  • D972AMC18UMAR2 ()
  • AMC18UMAR0 ()


  • Orthodontic archwire

Archwire - D972AMC1825UMAREU2

18x25 Premium Thermal - NiTi - Euro - U
Acme Monaco Corporation
AMC1825UMAREU
In Commercial Distribution

  • D972AMC1825UMAREU2 ()
  • AMC1825UMAREU0 ()


  • Orthodontic archwire

Archwire - D972AMC1825UMAR2

18x25 Premium Thermal - NiTi - Nat - U
Acme Monaco Corporation
AMC1825UMAR
In Commercial Distribution

  • D972AMC1825UMAR2 ()
  • AMC1825UMAR0 ()


  • Orthodontic archwire
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