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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E2 Split Mounting Hardware (pair); includes E2 EasySet Mounting Pin Interface Brackets. Optional mounting hardware for Matrx E2 Backs (18H/20H). Allows for avoidance of frame obstacles. Quick-release design.
Motion Concepts Inc
E2SMH
In Commercial Distribution

  • 07540147001223 ()
E2SMH

  • Wheelchair back rest positioner
MX2 Removable Mounting Hardware (pair) for use with the Matrx MX2 Back. (Fits 3/4", 7/8" and 1" back canes). Quick-release design.
Motion Concepts Inc
IMX2QRH
In Commercial Distribution

  • 07540147000288 ()
IMX2QRH

  • Wheelchair back rest positioner
MX2 Fixed Mounting Hardware (pair) for use with the Matrx MX2 Back. (Fits 3/4", 7/8" and 1" back canes). Requires tools for removal.
Motion Concepts Inc
IMX2CFH
In Commercial Distribution

  • 07540147000264 ()
IMX2CFH

  • Wheelchair back rest positioner
Heavy-Duty MiniSet Mounting Hardware (pair) for Matrx Mini Backs. (Fits 3/4", 7/8" and 1" back canes). Quick-release design. Recommended for high tone or heavy use applications
Motion Concepts Inc
MSHD
In Commercial Distribution

  • 07540147000196 ()
MSHD

  • Wheelchair back rest positioner
Heavy-Duty Easy-Set Mounting Hardware (pair). Standard with all Heavy-Duty Matrx Elite and PB Back Models. Quick-release design. Recommended for high tone or heavy intended use.
Motion Concepts Inc
HDMH
In Commercial Distribution

  • 07540147000172 ()
HDMH

  • Wheelchair back rest positioner
ON-Q* Fixed Flow Pump Kits With ON-Q* Soaker* Catheter
Avanos Medical, Inc.
45066
In Commercial Distribution

  • 10193494450660 ()
  • 00193494450663 ()

  • Fill Volume (ml)
  • Total Volume: 100 Milliliter
PS2501-N

  • Gas chromatography analyser injection port IVD
Waya® Rehab is a software only medical device to support rehabilitation under the guidance of a qualified healthcare professional.
WELLOVATE, LLC
1
In Commercial Distribution

  • G741WHREHABV10 ()


  • Biomechanical function analysis/interactive rehabilitation system
  • Biomechanical function analysis/rehabilitation software
A software-only medical device intended for cervical region rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of physical exercises according to their treating medical practitioner's guidelines. The N-140 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. N-140 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.
XR HEALTH IL LTD
N-140 (Rotate)
In Commercial Distribution

  • 07290016986099 ()


  • Biomechanical function analysis/interactive rehabilitation system
  • Biomechanical function analysis/rehabilitation software
A software-only medical device intended for upper extremity and full body rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of physical exercises according to their treating medical practitioner's guidelines. The MT-220 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. MT-220 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.
XR HEALTH IL LTD
MT-220 (Balloon Blast)
In Commercial Distribution

  • 07290016986082 ()


  • Biomechanical function analysis/interactive rehabilitation system
  • Biomechanical function analysis/rehabilitation software
A software-only medical device intended for motor-cognitive rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of motor-cognitive exercises according to their treating medical practitioner's guidelines. The MC-320 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. MC-320 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.
XR HEALTH IL LTD
MC-320 (Color Match)
In Commercial Distribution

  • 07290016986075 ()


  • Biomechanical function analysis/interactive rehabilitation system
  • Biomechanical function analysis/rehabilitation software
Prone Breast, Hardware Kit, Head Rest Carriage, Replacement
Bionix, LLC
PBRT-6303
In Commercial Distribution

  • 00714646001450 ()
PBRT-6303

  • Radiological whole-body positioner
OSI Jackson Sling with Dual Slot Plastic Hardware
STERIS CORPORATION
Table Pads
In Commercial Distribution

  • 00724995204952 ()
MP1013

  • Multifunction body cushion
SHOULDER STRAP ASSEMBLY, INCLUDES: PLASTIC TAB, STRAP, HARDWARE
PMT CORPORATION
1201-48
In Commercial Distribution

  • 00650551044895 ()
1201-48

  • Cervical spine immobilization system, single-use
Universal Full Length Arm Pad w/ Hardware (ea)
PROACTIVE MEDICAL PRODUCTS, LLC
PP-RAPF
In Commercial Distribution

  • 05060488573071 ()

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

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

  • 05060488573057 ()

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

  • Wheelchair armrest
COUPLING HARDWARE KIT, EXTENSION ARM TO POST (OSP-10G-EA-R)
AADCO MEDICAL, INC.
OSP-241426S
In Commercial Distribution

  • 00840348503647 ()
OSP-241426S

  • Custom-made medical device mount
GUERBET HARDWARE KIT, EXTENSION ARM TO COLUMN POST
AADCO MEDICAL, INC.
OSP-241425S
In Commercial Distribution

  • 00840348503630 ()
OSP-241425S

  • Custom-made medical device mount
GUERBET HARDWARE KIT, PLASTIC COVERS, LONG COLUMN ASSEMBLY
AADCO MEDICAL, INC.
OSP-241421S
In Commercial Distribution

  • 00840348503593 ()
OSP-241421S

  • Custom-made medical device mount
GUERBET HARDWARE KIT, PLASTIC COVERS, STANDARD COLUMN ASSEMBLY
AADCO MEDICAL, INC.
OSP-241420S
In Commercial Distribution

  • 00840348503586 ()
OSP-241420S

  • Custom-made medical device mount
GUERBET HARDWARE KIT, CARRIAGE ASSEMBLY TO TRACK ASSEMBLY
AADCO MEDICAL, INC.
OSP-241418S
In Commercial Distribution

  • 00840348503562 ()
OSP-241418S

  • Custom-made medical device mount
LOGIQ Fortis R3 to R4 Upgrade with Hardware
GE Ultrasound Korea Ltd.
Fortis R3 to R4 HW Upgrade
In Commercial Distribution

  • 00195278835802 ()
5946726

  • General-purpose ultrasound imaging system
Tri-Soft Headrest, 14" with POSAlinc Removable Adjustable Hardware
KI MOBILITY, LLC
Head Support
In Commercial Distribution

  • 00840363306032 ()

  • 14"
TS14PL

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

  • 00840363306025 ()

  • 10"
TS10PL

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

  • 00840363306018 ()

  • 14"
TS14MA

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

  • 00840363306001 ()

  • 10"
TS10MA

  • Wheelchair bracket/mount
Tri-Soft Headrest 14" with Posalinc Flip-Back Adjustable Hardware
KI MOBILITY, LLC
Head Support
In Commercial Distribution

  • 00840363366159 ()

  • 14"
TS14PLF

  • Wheelchair bracket/mount
Tri-Soft Headrest 10" with Posalinc Flip-Back Adjustable Hardware
KI MOBILITY, LLC
Head Support
In Commercial Distribution

  • 00840363366142 ()

  • 10"
TS10PLF

  • Wheelchair bracket/mount
Leica Biosystems Ariol Workstation PC for Legacy Hardware
Leica Biosystems Richmond, Inc.
23AUWS
In Commercial Distribution

  • 00849832003878 ()

  • Device Size Text, specify:


  • Desktop computer
Basket for TMR Mounting Hardware, (fits into 72152-A)
FLEXBAR MACHINE CORPORATION
72152-b
In Commercial Distribution

  • 00842102104831 ()
72152-b

  • Device sterilization/disinfection container, reusable
FJ-2000, Minimally Invasive Procedure Kit for Hardware (Sterile)
Paragon 28, Inc.
P65-001-0002-SK
In Commercial Distribution

  • 00889795131058 ()
P65-001-0002-SK

  • Surgical power tool system control unit, line-powered
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
Digital Medical Image Processor
OMEGA MEDICAL IMAGING, LLC
IPS-100
In Commercial Distribution

  • 00853901007032 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR v4.17
In Commercial Distribution

  • 00854344007764 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.16
In Commercial Distribution

  • 00854344007757 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.15
In Commercial Distribution

  • 00854344007740 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.14
In Commercial Distribution

  • 00854344007733 ()


  • X-ray system computer, diagnostic, general-purpose
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