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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K4 Deluxe Flip-Back Armrest Guides, w/ Hardware, Pair
COMPASS HEALTH BRANDS CORP.
X1WC4DAM21
In Commercial Distribution

  • 00815067013333 ()


  • Push-rim manual wheelchair, non-bariatric
K4 Deluxe Wheelchair Skirt Guard, Pair w/ Hardware
COMPASS HEALTH BRANDS CORP.
X1WC4DAM13
In Commercial Distribution

  • 00815067013258 ()


  • Push-rim manual wheelchair, non-bariatric
NEW STYLE STIRRUP W/ ATTACHMENT HARDWARE(24")- EA
UNITED METAL FABRICATORS, INC.
R1-3485
In Commercial Distribution

  • 00815235023720 ()


  • Heel stirrup
INNER BOTTOM RAIL WITH HARDWARE - PR - TRAVELER SE
GF HEALTH PRODUCTS, INC.
90763003A
In Commercial Distribution

  • M36890763003A1 ()
90763003A

  • Push-rim manual wheelchair, non-bariatric
E2 Easy-Set Fixed Mounting Hardware (pair). Optional mounting hardware for Matrx E2 Backs (18H/20H). Requires tools for removal.
Motion Concepts Inc
ESFX
In Commercial Distribution

  • 07540147000899 ()
ESFX

  • Wheelchair back rest positioner
Integrity
ELEKTA LIMITED
1526754
In Commercial Distribution

  • 05060191071062 ()


  • Accelerator system computer
XR-29 Solution v1.0
AGILITI HEALTH, INC.
v1.0
In Commercial Distribution

  • 00810040260001 ()


  • CT system computer
Medic Vision’s SafeCT-29 provides a vendor-neutral Radiation Dose Check functionality, in accordance with the Dose Check feature that is specified by the NEMA XR-25 Standard. The device is a software and hardware system which includes Computer, dedicated display and controls. The SafeCT-29 is interfaced to CT scanners that are not equipped with the Dose Check function. The device is connected to the CT Console video output via a standard video connector. The SafeCT-29 Computer’s internal video splitter captures the CT Console display video, in real time, without affecting neither the CT console itself nor its display. This analog video signal is digitized by a video grabber. The SafeCT-29 software analyzes the digital input video using OCR software continuously. The radiation dose information as calculated by the scanner and displayed to the CT operator is extracted and analyzed in real time. The SafeCT- 29 captures the video of the CT Console display in real time, without affecting neither the CT console itself nor its display and workflow. As specified by NEMA XR-25 Standard, the safeCT-29 notifies and alerts the CT operators, prior to a scan, if the estimated dose index is above the predefined values set by the operating group, practice, or organization. SafeCT-29 prevents continuing an over-the-limit scan unless dose levels are reconfirmed by the operator, in accordance with NEMA XR-29*.The device records the details of such events, including the operator details and decisions. This record is available to the user.
MEDIC VISION - IMAGING SOLUTIONS LTD
1.0
In Commercial Distribution

  • 07290016836202 ()
  • 00729001683639 ()


  • CT system computer
E2 MiniSet Fixed Mounting Hardware (pair). Optional mounting hardware for Matrx E2 Backs (16H or less). Requires tools to remove.
Motion Concepts Inc
MSFX
In Commercial Distribution

  • 07540147000882 ()
MSFX

  • Wheelchair back rest positioner
Easy-Set Mounting Hardware (pair) for use on 1-1/4" back canes. Hardware for Matrx Elite and PB Backs. Quick-release design.
Motion Concepts Inc
PBMH-X
In Commercial Distribution

  • 07540147000257 ()
PBMH-X

  • Wheelchair back rest positioner
Easy-Set Mounting Hardware (pair) for use on 1-1/8" back canes. Hardware for Matrx Elite and PB Backs. Quick-release design.
Motion Concepts Inc
PBMH-Q
In Commercial Distribution

  • 07540147000233 ()
PBMH-Q

  • Wheelchair back rest positioner
Locking Bar for Back Plate includes Hardware (NEMOTO ONLY)
Innovative Medical Products, Inc
7541
In Commercial Distribution

  • 00696588001999 ()
7541

  • Operating table torso positioner
Locking Bar for Anterior Support & Hyperflexion Plate includes Hardware
Innovative Medical Products, Inc
7540
In Commercial Distribution

  • 00696588001982 ()
7540

  • Operating table torso positioner
Universal Urethane Full Length Arm Pad w/ Hardware (ea)
PROACTIVE MEDICAL PRODUCTS, LLC
PP-RAPUF
In Commercial Distribution

  • 05060488573347 ()

  • Height: 4 Inch
  • Length: 8 Inch
  • Width: 2 Inch
PP-RAPUF

  • Wheelchair armrest
Universal Urethane Desk Length Arm Pad w/ Hardware (ea)
PROACTIVE MEDICAL PRODUCTS, LLC
PP-RAPUD
In Commercial Distribution

  • 05060488573330 ()

  • Width: 2 Inch
  • Height: 4 Inch
  • Length: 8 Inch
PP-RAPUD

  • Wheelchair armrest
32" SHELF FOR KM VBM CM CARRIERS INCLUDES HARDWARE
SKYTRON LLC
XMSH
In Commercial Distribution

  • 10841736114886 ()


  • General utility supply system, ceiling-mounted
22" SHELF FOR PM VBM CM CARRIERS INCLUDES HARDWARE
SKYTRON LLC
PMSH
In Commercial Distribution

  • 10841736114862 ()


  • General utility supply system, ceiling-mounted
16.5" SHELF FOR KM VBM CM CARRIERS INCLUDES HARDWARE
SKYTRON LLC
KMSH
In Commercial Distribution

  • 10841736114855 ()


  • General utility supply system, ceiling-mounted
AMG PartsAMG Parts Product Description: HARDWARE FOR SEAT,1EA
Drive Devilbiss Healthcare
B01-816
Not in Commercial Distribution

  • 00057565939351 ()


  • Wheelchair seat cushion
LOGIQ E10s R2/R3 to R4 Upgrade with Hardware
GE Ultrasound Korea Ltd.
E10s R2R3 to R4 HW Upgrade
In Commercial Distribution

  • 00195278835765 ()
5946722

  • General-purpose ultrasound imaging system
Outer Container Only (for TMR Mounting Hardware and Rings)
FLEXBAR MACHINE CORPORATION
72152-a
In Commercial Distribution

  • 00842102104824 ()
72152-a

  • Device sterilization/disinfection container, reusable
Container and Baskets for TMR Mounting Hardware and Rings
FLEXBAR MACHINE CORPORATION
72152
In Commercial Distribution

  • 00842102104763 ()
72152

  • Device sterilization/disinfection container, reusable
Tri-Soft Headrest, 14" with Standard Straight Removable Adjustable Hardware
KI MOBILITY, LLC
Head Support
In Commercial Distribution

  • 00840363305998 ()

  • 14"
TS14SS

  • Wheelchair bracket/mount
Tri-Soft Headrest, 10" with Standard Straight Removable Adjustable Hardware
KI MOBILITY, LLC
Head Support
In Commercial Distribution

  • 00840363305981 ()

  • 10"
TS10SS

  • Wheelchair bracket/mount
Comfort Soft Headrest, 8" with POSAlinc Removable Adjustable Hardware
KI MOBILITY, LLC
Head Support
In Commercial Distribution

  • 00840363305868 ()

  • 8"
CS08PL

  • Wheelchair bracket/mount
Comfort Soft Headrest, 14" with Multi-Axis Removable Adjustable Hardware
KI MOBILITY, LLC
Head Support
In Commercial Distribution

  • 00840363305851 ()

  • 14"
CS14MA

  • Wheelchair bracket/mount
Comfort Soft Headrest, 14" with POSAlinc Removable Adjustable Hardware
KI MOBILITY, LLC
Head Support
In Commercial Distribution

  • 00840363305882 ()

  • 14"
CS14PL

  • Wheelchair bracket/mount
Comfort Soft Headrest, 10" with POSAlinc Removable Adjustable Hardware
KI MOBILITY, LLC
Head Support
In Commercial Distribution

  • 00840363305875 ()

  • 10"
CS10PL

  • Wheelchair bracket/mount
Comfort Soft Headrest, 10" with Multi-Axis Removable Adjustable Hardware
KI MOBILITY, LLC
Head Support
In Commercial Distribution

  • 00840363305844 ()

  • 10"
CS10MA

  • Wheelchair bracket/mount
Comfort Soft Headrest, 8" with Multi-Axis Removable Adjustable Hardware
KI MOBILITY, LLC
Head Support
In Commercial Distribution

  • 00840363305837 ()

  • 8"
CS08MA

  • Wheelchair bracket/mount
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