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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4 x 5 Lateral Pads with Swing Away Mounting Hardware - Pair
KI MOBILITY, LLC
PB
In Commercial Distribution

  • 00840363306070 ()

  • 4 x 5
PBLS4X5PP

  • Wheelchair bracket/mount
3 x 4 Lateral Pads with Swing Away Mounting Hardware - Pair
KI MOBILITY, LLC
PB
In Commercial Distribution

  • 00840363306063 ()

  • 3 x 4
PBLS3X4PP

  • Wheelchair bracket/mount
Contour Positioning Pad, 10" x 7.5" with POSAlinc Removable Adjustable Hardware
KI MOBILITY, LLC
Head Support
In Commercial Distribution

  • 00840363305974 ()

  • 10" x 7.5"
CP10PL

  • Wheelchair bracket/mount
Contour Positioning Pad, 9" x 6.5" with POSAlinc Removable Adjustable Hardware
KI MOBILITY, LLC
Head Support
In Commercial Distribution

  • 00840363305967 ()

  • 9" x 6.25"
CP09PL

  • Wheelchair bracket/mount
Contour Positioning Pad, 8" x 6.25" with POSAlinc Removable Adjustable Hardware
KI MOBILITY, LLC
Head Support
In Commercial Distribution

  • 00840363305950 ()

  • 8" x 6.25"
CP08PL

  • Wheelchair bracket/mount
Contour Positioning Pad, 10" x 7.5" with Multi-Axis Removable Adjustable Hardware
KI MOBILITY, LLC
Head Support
In Commercial Distribution

  • 00840363305943 ()

  • 10" x 7.5"
CP10MA

  • Wheelchair bracket/mount
Contour Positioning Pad, 9" x 6.5" with Multi-Axis Removable Adjustable Hardware
KI MOBILITY, LLC
Head Support
In Commercial Distribution

  • 00840363305936 ()

  • 9" x 6.25"
CP09MA

  • Wheelchair bracket/mount
Contour Positioning Pad, 8" x 6.25" with Multi-Axis Removable Adjustable Hardware
KI MOBILITY, LLC
Head Support
In Commercial Distribution

  • 00840363305929 ()

  • 8" x 6.25"
CP08MA

  • Wheelchair bracket/mount
BedsRails Product Description: Spectrum Bed,1/4 Bed Rail and Hardware
Drive Devilbiss Healthcare
SSB-206
Not in Commercial Distribution

  • 00822383247731 ()


  • Bedrail
SmartPrep® 3 Multi-Cellular Processing System, Red Cell Reduction Hardware Kit
TERUMO BCT, INC.
51499
Not in Commercial Distribution

  • 05020583514997 ()


  • Haematological concentrate system centrifuge
LOGIQ E10s R2/R3 to R4 Upgrade with Hardware including Wireless
GE Ultrasound Korea Ltd.
E10s R2R3 to R4 HW Upgrade W
In Commercial Distribution

  • 00195278835789 ()
5946724

  • General-purpose ultrasound imaging system
E2 Heavy-Duty EasySet Removable Mounting Hardware (pair); includes E2 EasySet Mounting Pin Interface Brackets. Optional mounting hardware for Matrx E2 Backs (18H/20H). Quick-release design.
Motion Concepts Inc
E2HDMH
In Commercial Distribution

  • 07540147001216 ()
E2HDMH

  • Wheelchair back rest positioner
E2 Heavy-Duty MiniSet Removable Mounting Hardware (pair); includes E2 MiniSet Mounting Pin Interface Brackets. Optional mounting hardware for Matrx E2 Backs (18H/20H). Quick-release design.
Motion Concepts Inc
E2MSHD
In Commercial Distribution

  • 07540147001209 ()
E2MSHD

  • Wheelchair back rest positioner
TPS Software
XCISION MEDICAL SYSTEMS, LLC
Model A
In Commercial Distribution

  • 00850002615029 ()
XMSGP030A09.07-001

  • Stereotactic system application software
TCS Software
XCISION MEDICAL SYSTEMS, LLC
Model A
In Commercial Distribution

  • 00850002615012 ()
XMSGP030A09.06-101

  • Stereotactic system application software
SFTW KIT 9735696 STEALTHCONNECT SYS
MEDTRONIC NAVIGATION, INC.
9735696
In Commercial Distribution

  • 00643169705432 ()


  • Stereotactic system application software
SOFTWARE MMT-7310 SOLNS EA CGMS V3.0C EN
MEDTRONIC MINIMED, INC.
MMT-7310
In Commercial Distribution

  • 00613994675293 ()


  • Home healthcare information system
Software medical device. Intended for use by professional healthcare providers as an intra-operative image-guidance tool used during surgical and interventional therapy.
Philips Medical Systems Nederland B.V.
ClarifEye - 1
In Commercial Distribution

  • 00884838104570 ()
002120

  • Stereotactic system application software
IntelliSpace Perinatal Large Architecture is a software-only offering and includes three separate versions of IntelliSpace Perinatal.
Philips Medical Systems Hsg
IntelliSpace Perinatal K Large Arch.
In Commercial Distribution

  • 00884838084483 ()
867061

  • Obstetrics information system
UroNAV Fusion Biopsy System
Philips DS North America LLC
784001
In Commercial Distribution

  • 00884838083592 ()


  • Stereotactic system application software
UroNav Fusion Biopsy Software
Philips DS North America LLC
784015
In Commercial Distribution

  • 00884838081550 ()


  • Stereotactic system application software
UroNAV Fusion Biopsy System
Philips DS North America LLC
784012
In Commercial Distribution

  • 00884838081543 ()


  • Stereotactic system application software
No Description
BL HEALTHCARE, INC.
3.0
In Commercial Distribution

  • 00863353000307 ()


  • Home healthcare information system
UroNAV 1.x to 2.0 Upgrade
Philips DS North America LLC
784011
In Commercial Distribution

  • 00884838066991 ()


  • Stereotactic system application software
A convenient, easy-to-use, tabletop physiological monitoring system.
VITERION CORPORATION
3.5.0.en
Not in Commercial Distribution

  • 00852579007009 ()
  • 10852579007006 ()

  • Weight: 3.800 Pound
  • Depth: 3.900 Inch
  • Width: 9.720 Inch
  • Height: 7.680 Inch
81842478

  • Home healthcare information system
PeriWatch Surveillance is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store, and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. It organizes clinical data that would normally be provided on paper records or other clinical systems and devices. The system also serves as a decision support tool and electronic medical record.
PERIGEN INC.
2024.1.000
In Commercial Distribution

  • 00860003483558 ()


  • Obstetrics information system
No Description
PERIGEN INC.
2022.1.002
In Commercial Distribution

  • 00860003483541 ()


  • Obstetrics information system
PeriWatch Surveillance is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store, and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. It organizes clinical data that would normally be provided on paper records or other clinical systems and devices. The system also serves as a decision support tool and electronic medical record.
PERIGEN INC.
2022.1.0
In Commercial Distribution

  • 00860003483534 ()


  • Obstetrics information system
PeriWatch Surveillance is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store, and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. It organizes clinical data that would normally be provided on paper records or other clinical systems and devices. The system also serves as a decision support tool and electronic medical record.
PERIGEN INC.
2021.2.0
Not in Commercial Distribution

  • 00860003483527 ()


  • Obstetrics information system
PeriWatch Surveillance is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store, and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. It organizes clinical data that would normally be provided on paper records or other clinical systems and devices. The system also serves as a decision support tool and electronic medical record.
PERIGEN INC.
2021.1.0
In Commercial Distribution

  • 00860003483510 ()


  • Obstetrics information system
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