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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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Axiom - 00840363306100

3 x 4 Lateral Pads with Fixed Mounting Hardware - Pair
KI MOBILITY, LLC
PL
In Commercial Distribution

  • 00840363306100 ()

  • 3 x 4
PLLF3x4PP

  • Wheelchair bracket/mount

Axiom - 00840363306056

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

  • 00840363306056 ()

  • 4 x 5
PBLF4X5PP

  • Wheelchair bracket/mount

Axiom - 00840363306049

3 x 4 Lateral Pads with Fixed Mounting Hardware - Pair
KI MOBILITY, LLC
PB
In Commercial Distribution

  • 00840363306049 ()

  • 3 x 4
PBLF3x4PP

  • Wheelchair bracket/mount

Axiom - 00840363305820

Comfort Soft Headrest, 14" with Standard Straight Removable Adjustable Hardware
KI MOBILITY, LLC
Head Support
In Commercial Distribution

  • 00840363305820 ()

  • 14"
CS14SS

  • Wheelchair bracket/mount

Axiom - 00840363305813

Comfort Soft Headrest, 10" with Standard Straight Removable Adjustable Hardware
KI MOBILITY, LLC
Head Support
In Commercial Distribution

  • 00840363305813 ()

  • 10"
CS10SS

  • Wheelchair bracket/mount

Axiom - 00840363305806

Comfort Soft Headrest, 8" with Standard Straight Removable Adjustable Hardware
KI MOBILITY, LLC
Head Support
In Commercial Distribution

  • 00840363305806 ()

  • 8"
CS08SS

  • Wheelchair bracket/mount

Probasics - 00815067013364

K4 Deluxe 20" Seat Extender w/ Seat Tube and Hardware
COMPASS HEALTH BRANDS CORP.
X1WC4DAM24
In Commercial Distribution

  • 00815067013364 ()


  • Push-rim manual wheelchair, non-bariatric

Probasics - 00815067013357

K4 Deluxe 18" Seat Extender w/ Seat Tube and Hardware
COMPASS HEALTH BRANDS CORP.
X1WC4DAM23
In Commercial Distribution

  • 00815067013357 ()


  • Push-rim manual wheelchair, non-bariatric

Probasics - 00815067013340

K4 Deluxe 16" Seat Extender w/ Seat Tube and Hardware
COMPASS HEALTH BRANDS CORP.
X1WC4DAM22
In Commercial Distribution

  • 00815067013340 ()


  • Push-rim manual wheelchair, non-bariatric

Probasics - 00815067013166

K4 Deluxe 22" Seat Extender w/ Seat Tube and Hardware
COMPASS HEALTH BRANDS CORP.
X1WC4DAM25
In Commercial Distribution

  • 00815067013166 ()


  • Push-rim manual wheelchair, non-bariatric

UMF Medical - 00815235023751

20-1/8 IN. STIRRUP ASSEMBLY W/ ATTACHMENT HARDWARE(replaces R1-3016)
UNITED METAL FABRICATORS, INC.
R1-3534
In Commercial Distribution

  • 00815235023751 ()


  • Heel stirrup

Straumann SIRIOS X3 - 06973993442840

Straumann SIRIOS™ X3 Intraoral scanner Hardware As A Service
Alliedstar Medical Equipment Co., Ltd.
ST 300E
In Commercial Distribution

  • 06973993442840 ()
STS-6583448-H

  • Intraoral optical scanning system

HeRO duet - 00865536000234

A standalone HeRO monitor for two infants
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000234 ()


  • Neonatal/paediatric heart rate monitoring application software
  • Neonatal/paediatric heart rate monitoring hardware

HeRO solo - 00865536000227

A HeRO System for the private room
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000227 ()


  • Neonatal/paediatric heart rate monitoring application software
  • Neonatal/paediatric heart rate monitoring hardware

HeRO ES - 00865536000210

No Description
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000210 ()


  • Neonatal/paediatric heart rate monitoring application software
  • Neonatal/paediatric heart rate monitoring hardware

HeRO symphony - 00865536000203

Server based HeRO System
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000203 ()


  • Neonatal/paediatric heart rate monitoring hardware
  • Neonatal/paediatric heart rate monitoring application software

Prelude - 04260308110108

The Prelude software supports radiation therapy workflows for IntraOp Mobetron, a radiation treatment device. It assists to find product specific machine parameters for treatment and can send those proposals to the console of the device. The machine parameters are not intended to be used for direct control for the radiation device.
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
V1. EBRT
In Commercial Distribution

  • 04260308110108 ()


  • Radiation therapy software

Prelude - 04260308110092

The Prelude software supports radiation therapy workflows for IntraOp Mobetron, a radiation treatment device. It assists to find product specific machine parameters for treatment and can send those proposals to the console of the device. The machine parameters are not intended to be used for direct control for the radiation device.
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
V1. IORT
In Commercial Distribution



  • Radiation therapy software

Prelude - 04260308110078

The Prelude software supports intra-operative radiation therapy workflows with intra-operative radiation devices like IntraOp Mobetron. It assists to find product specific machine parameters for treatment and can send those proposals to the intra-operative radiation device. The machine parameters are not intended to be used for direct control for the radiation device. Machine Output Quality can be visualized and recorded over time for quality assurance.
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
V1.
In Commercial Distribution

  • 04260308110078 ()


  • Radiation therapy software

VeriSuite - 04260308110023

No Description
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
1.8
In Commercial Distribution

  • 04260308110023 ()


  • Radiation therapy software
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