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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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Eversense NOW Remote Monitoring mobile application (iOS) is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information.
SENSEONICS, INCORPORATED
FG-5901-01-300
In Commercial Distribution

  • 00817491021267 ()
FG-5901-01-300

  • Implantable glucose monitoring system
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
In Commercial Distribution

75750

  • Rectal irrigation system application software
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
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
Not in Commercial Distribution

  • 07392532242373 ()
75750

  • Rectal irrigation system application software
No Description
Philips Ultrasound LLC
795160
In Commercial Distribution

  • 00884838103399 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Single use disposable application pad adhesive for use with dorsaVi Version 5 MDM Sensors for Movement Suite Kits.
DORSAVI LTD
30Min-DAP
In Commercial Distribution

  • B758000035630 ()
  • B758000RDA326 ()
0356-30

  • Psychophysiological biofeedback system
No Description
Zhejiang Shuyou Surgical Instrument Co.,Ltd.
VIX-A015腔镜电极
In Commercial Distribution

  • 06924274950608 ()


  • Open-surgery electrosurgical electrode, monopolar, single-use
DMDM BASIC ASSEMBLY,30 PCT
PARKER-HANNIFIN CORPORATION
40151601
In Commercial Distribution

  • 00816711020417 ()


  • Oxygen/air/nitrous oxide breathing gas mixer
INTL DMDM BASIC ASSY,30 CANADA
PARKER-HANNIFIN CORPORATION
40151617
In Commercial Distribution

  • 00816711020165 ()


  • Oxygen/air/nitrous oxide breathing gas mixer
DMDM REMOTE ASSY,30 PCT
PARKER-HANNIFIN CORPORATION
40152601
In Commercial Distribution

  • 00816711020196 ()


  • Oxygen/air/nitrous oxide breathing gas mixer
INTL DMDM BASIC ASSY, 30
PARKER-HANNIFIN CORPORATION
40151619
In Commercial Distribution

  • 00816711020189 ()


  • Oxygen/air/nitrous oxide breathing gas mixer
INTL DMDM BASIC ASSY,30% ITALY
PARKER-HANNIFIN CORPORATION
40151618
In Commercial Distribution

  • 00816711020172 ()


  • Oxygen/air/nitrous oxide breathing gas mixer
INTL DMDM BASIC ASSY,50% DUTCH
PARKER-HANNIFIN CORPORATION
40151616
In Commercial Distribution

  • 00816711020158 ()


  • Oxygen/air/nitrous oxide breathing gas mixer
INTL DMDM BASIC ASSY,AUSTRALIA
PARKER-HANNIFIN CORPORATION
40151615
In Commercial Distribution

  • 00816711020141 ()


  • Oxygen/air/nitrous oxide breathing gas mixer
INTL DMDM BASIC ASSY, SWEDEN
PARKER-HANNIFIN CORPORATION
40151614
In Commercial Distribution

  • 00816711020134 ()


  • Oxygen/air/nitrous oxide breathing gas mixer
DMDM BASIC ASSY,30 PCT,L FIT,2
PARKER-HANNIFIN CORPORATION
40151604
In Commercial Distribution

  • 00816711020127 ()


  • Oxygen/air/nitrous oxide breathing gas mixer
DMDM BASIC ASSY,30 PCT,L FIT,1
PARKER-HANNIFIN CORPORATION
40151603
In Commercial Distribution

  • 00816711020110 ()


  • Oxygen/air/nitrous oxide breathing gas mixer
DMDM BASIC ASSY,30 PCT,ST FT,2
PARKER-HANNIFIN CORPORATION
40151602
In Commercial Distribution

  • 00816711020103 ()


  • Oxygen/air/nitrous oxide breathing gas mixer
The Fistula Brush can be used for probing of the fistula tract and for debridement before using the OTSC Proctology • it is used to clean the fistula tract and remove granulation tissue • supports obliteration of fistula tract
Ovesco Endoscopy AG
Proctology
In Commercial Distribution

  • 04260206310631 ()
  • 4260206310280 ()

  • working length 30 cm
200.62

  • General-purpose cytology brush
PUSH PIN
KLS-Martin L.P.
25-408-01-75
In Commercial Distribution

  • 10888118039993 ()
  • 00888118039996 ()


  • Suturing needle holder, single-use
BABY TISCHLER BIOPSY PUNCH, 10", 2MMX4MM BITE
HNM STAINLESS, LLC.
HNM-1-52-6550
In Commercial Distribution

  • 00842962162149 ()
HNM-1-52-6550

  • Surgical tamp, reusable
DISPOSABLE INSTRUMENT SET
HNM STAINLESS, LLC.
HNM-18-00-0304
In Commercial Distribution

  • 00842962161692 ()
HNM-18-00-0304

  • Surgical tamp, reusable
1/4" QUICK CONNECT AXIAL HANDLE
HNM STAINLESS, LLC.
HNM-18-0304-AH
In Commercial Distribution

  • 00842962161685 ()
HNM-18-0304-AH

  • Surgical tamp, reusable
SUTURE ANCHOR DELIVERY SYSTEM, PEEK SCREW, 4.5MM X 15MM, TWO SUTURE, STERILE
HNM STAINLESS, LLC.
HNM-77-4515
In Commercial Distribution

  • 00842962161401 ()
HNM-77-4515

  • Surgical tamp, reusable
FEMORAL RETRACTOR
TEDAN SURGICAL INNOVATIONS, L.L.C.
HS-0320
In Commercial Distribution

  • 00843059109771 ()


  • Surgical retractor/retraction system blade, reusable
SUPER FUKUDA RETRACTOR, PURPLE
TEDAN SURGICAL INNOVATIONS, L.L.C.
HS-0315
In Commercial Distribution

  • 00843059109764 ()


  • Surgical retractor/retraction system blade, reusable
RAKE RETRACTOR, 5", YELLOW
TEDAN SURGICAL INNOVATIONS, L.L.C.
HS-0254
Not in Commercial Distribution

  • 00843059109757 ()


  • Surgical retractor/retraction system blade, reusable
RAKE RETRACTOR, 3", YELLOW
TEDAN SURGICAL INNOVATIONS, L.L.C.
HS-0252
In Commercial Distribution

  • 00843059109740 ()


  • Surgical retractor/retraction system blade, reusable
COBRA RETRACTOR, SMOOTH, PURPLE
TEDAN SURGICAL INNOVATIONS, L.L.C.
HS-0242
Not in Commercial Distribution

  • 00843059109733 ()


  • Surgical retractor/retraction system blade, reusable
COBRA RETRACTOR, SERRATED, PURPLE
TEDAN SURGICAL INNOVATIONS, L.L.C.
HS-0240
Not in Commercial Distribution

  • 00843059109726 ()


  • Surgical retractor/retraction system blade, reusable
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