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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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LEVEL ONE - 00888118092403

SIDE RAIL, 2.7 WHITE, FEMALE, W/HARDWARE
KLS-Martin L.P.
99-962-55-04
In Commercial Distribution

  • 00888118092403 ()


  • Surgical instrument/implant rack

LEVEL ONE - 00888118092397

SIDE RAIL, 2.3 BLACK, FEMALE, W/HARDWARE
KLS-Martin L.P.
99-962-54-04
In Commercial Distribution

  • 00888118092397 ()


  • Surgical instrument/implant rack

LEVEL ONE - 00888118092380

SIDE RAIL, 2.0 RED, FEMALE, W/HARDWARE
KLS-Martin L.P.
99-962-53-04
In Commercial Distribution

  • 00888118092380 ()


  • Surgical instrument/implant rack

LEVEL ONE - 00888118092373

SIDE RAIL, 1.5 GREEN, FEMALE, W/HARDWARE
KLS-Martin L.P.
99-962-52-04
In Commercial Distribution

  • 00888118092373 ()


  • Surgical instrument/implant rack

FIREBIRD SFS - 18257200082063

EVLOUTION-C, REMOVAL KIT, CERVICAL SPINE HARDWARE (ES-20001)
Orthofix US LLC
450304-0001
In Commercial Distribution

  • 18257200082063 ()
ES-20001

  • Bone-screw internal spinal fixation system, non-sterile

ASCENT LE - 18257200082056

EVOLUTION, REMOVAL KIT, THORACOLUMBAR SPINE HARDWARE (ES-0005)
Orthofix US LLC
450303-0001
In Commercial Distribution

  • 18257200082056 ()
ES-0005

  • Bone-screw internal spinal fixation system, non-sterile

Medline - 40080196292494

HARDWARE,MOUNTING,F/1232 H/F BOARDS
MEDLINE INDUSTRIES, INC.
FCE1232HDW
In Commercial Distribution

  • 40080196292494 ()
FCE1232HDW

  • Hydraulic hospital bed
  • Basic electric hospital bed

PILLING - 34026704655138

BOX ACCESSORY W/HARDWARE 1.5"X3.5"X1"
TELEFLEX INCORPORATED
IPN022611
In Commercial Distribution

  • 14026704655134 ()
  • 34026704655138 ()

  • Length: 10.5 Inch
  • Width: 5 Inch
  • Height: 2 Inch
P37305

  • Device sterilization/disinfection container, reusable

Dimensions - 15420045512641

Contrast Enhanced Digital Mammography Imaging Kit
Hologic, Inc.
CEDM Hardware Kit
In Commercial Distribution

  • 15420045512641 ()
ASY-14055

  • Stationary mammographic x-ray system, digital

Everest & Jennings - M368907632C1A1

CROSSBRACE 16W - ADJUSTABLE DEPTH & CBOLT-PR (INCLUDES 4 LINKAGES,2 SADDLE BUSHINGS, 2 CRADDLE AND HARDWARE, 2 GASKETS & HARDWARE)
GF HEALTH PRODUCTS, INC.
907632C1A
In Commercial Distribution

  • M368907632C1A1 ()
907632C1A

  • Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

PowerLook PRO+ Hardware Platform - 00850008977107

No Description
Icad, Inc.
DSC018-01
In Commercial Distribution

  • 00850008977107 ()


  • Radiology DICOM image processing application software

Ablation Platform Mounting Hardware - 00873263007334

Platform Attachment Set
FHC, INC.
C0257-00733
In Commercial Distribution

  • 00873263007334 ()
C0257

  • Neurological stereotactic surgery system

Swifty transp. tie-down hardware - 04034089054940

No Description
Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft
9800068300000
In Commercial Distribution

  • 04034089054940 ()


  • Assistive pushchair

Mouting hardware special headrest - 04034089052120

No Description
Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft
9800062680000
In Commercial Distribution

  • 04034089052120 ()


  • Assistive pushchair

neuromate planning station hardware - 03662724000758

No Description
RENISHAW MAYFIELD
PC Cart (Workstation Cart)
In Commercial Distribution

  • 03662724000758 ()
043.0015

  • Neurological stereotactic surgery system

Neuromate Planning Station Hardware - 03662724000451

No Description
RENISHAW MAYFIELD
neuroinspire PC - Laptop US
In Commercial Distribution

  • 03662724000451 ()
001.0130

  • Neurological stereotactic surgery system

neuromate planning station hardware - 03662724000444

No Description
RENISHAW MAYFIELD
neuroinspire PC - Desktop US
In Commercial Distribution

  • 03662724000444 ()
001.0119

  • Neurological stereotactic surgery system

Varioguide Hardware (Version G) - 04056481000967

No Description
Brainlab AG
55950-70G
In Commercial Distribution

  • 04056481000967 ()
55950-70G

  • Robotic surgical navigation system

E2 Split Mounting Hardware - 07540147001223

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 - 07540147000288

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 - 07540147000264

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 - 07540147000196

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 - 07540147000172

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

System 4 MVP - 00718175004401

System 4 MVP
BIODEX MEDICAL SYSTEMS, INC.
852-000
In Commercial Distribution

  • 00718175004401 ()
852-000

  • Biomechanical function analysis system, force-testing, stationary

System 4 Quick Set - 00718175004203

System 4 Quick Set
BIODEX MEDICAL SYSTEMS, INC.
840-000
In Commercial Distribution

  • 00718175004203 ()
840-000

  • Biomechanical function analysis system, force-testing, stationary

MJS System 3 Upgrade - 00718175004067

Biodex Multi-Joint-System 3 Rev.1 UpGrade
BIODEX MEDICAL SYSTEMS, INC.
850-822
Not in Commercial Distribution

  • 00718175004067 ()
850-822

  • Biomechanical function analysis system, force-testing, stationary

System 4 Pro - 00718175004005

Biodex System 4 Pro
BIODEX MEDICAL SYSTEMS, INC.
850-000
In Commercial Distribution

  • 00718175004005 ()
850-000

  • Biomechanical function analysis system, force-testing, stationary

Prism - 10850390007380

A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks.
BTE TECHNOLOGIES, INC.
Prism1
In Commercial Distribution

  • 10850390007380 ()


  • Biomechanical function analysis system, force-testing, stationary

Provider Test Kit (PTK) - 10850390007359

A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks.
BTE TECHNOLOGIES, INC.
1
In Commercial Distribution

  • 10850390007359 ()


  • Biomechanical function analysis system, force-testing, stationary

EvalTech - 10850390007328

A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks.
BTE TECHNOLOGIES, INC.
EvalTech
In Commercial Distribution

  • 10850390007328 ()


  • Biomechanical function analysis system, force-testing, stationary
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