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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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Probasics - 00815067013159

K4 Deluxe 20" Seat Upholstery w/ Hardware
COMPASS HEALTH BRANDS CORP.
X1WC4DAM07
In Commercial Distribution

  • 00815067013159 ()


  • Push-rim manual wheelchair, non-bariatric

Probasics - 00815067013142

K4 Deluxe 22" Seat Upholstery w/ Hardware
COMPASS HEALTH BRANDS CORP.
X1WC4DAM08
In Commercial Distribution

  • 00815067013142 ()


  • Push-rim manual wheelchair, non-bariatric

Probasics - 00815067013128

K4 Deluxe 18" Seat Upholstery w/ Hardware
COMPASS HEALTH BRANDS CORP.
X1WC4DAM06
In Commercial Distribution

  • 00815067013128 ()


  • Push-rim manual wheelchair, non-bariatric

Probasics - 00815067013111

K4 Deluxe 16" Seat Upholstery w/ Hardware
COMPASS HEALTH BRANDS CORP.
X1WC4DAM05
In Commercial Distribution

  • 00815067013111 ()


  • Push-rim manual wheelchair, non-bariatric

Probasics - 00815067013081

K4 Deluxe Single Arm Drive Hardware Included
COMPASS HEALTH BRANDS CORP.
X1WC4DAM02
In Commercial Distribution

  • 00815067013081 ()


  • Push-rim manual wheelchair, non-bariatric

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

NA - 07613327053104

Sterilization Tray for Arthroscopy Access Hardware XL
STRYKER CORPORATION
0295800200
In Commercial Distribution

  • 07613327053104 ()
0295800200

  • Device sterilization/disinfection container, reusable

NA - 07613327051476

Sterilization Tray for Autoclavable Endoscope and Hardware
STRYKER CORPORATION
0233032116
In Commercial Distribution

  • 07613327051476 ()
0233032116

  • Device sterilization/disinfection container, reusable

LEVEL ONE - 00888118092335

SIDE RAIL, 2.7 WHITE, MALE, W/HARDWARE
KLS-Martin L.P.
99-962-45-04
In Commercial Distribution

  • 00888118092335 ()


  • Surgical instrument/implant rack

LEVEL ONE - 00888118092328

SIDE RAIL, 2.3 BLACK, MALE, W/HARDWARE
KLS-Martin L.P.
99-962-44-04
In Commercial Distribution

  • 00888118092328 ()


  • Surgical instrument/implant rack

LEVEL ONE - 00888118092311

SIDE RAIL, 2.0 RED, MALE, W/HARDWARE
KLS-Martin L.P.
99-962-43-04
In Commercial Distribution

  • 00888118092311 ()


  • Surgical instrument/implant rack

LEVEL ONE - 00888118092304

SIDE RAIL, 1.5 GREEN, MALE, W/HARDWARE
KLS-Martin L.P.
99-962-42-04
In Commercial Distribution

  • 00888118092304 ()


  • Surgical instrument/implant rack

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

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

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

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

ER - 10850390007311

No Description
BTE TECHNOLOGIES, INC.
ER
Not in Commercial Distribution

  • 10850390007311 ()


  • Biomechanical function analysis system, force-testing, stationary

PrimusRS - 10850390007243

A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer offers isometric, isotonic, isokinetic, eccentric, concentric, and continuous passive motion modes, as well as many adapters for isolated joint and compound motions.
BTE TECHNOLOGIES, INC.
PrimusRS
In Commercial Distribution

  • 10850390007243 ()


  • Biomechanical function analysis system, force-testing, stationary

Primus - 10850390007236

A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer offers isometric, isotonic, isokinetic, eccentric, concentric, and continuous passive motion modes, as well as many adapters for isolated joint and compound motions.
BTE TECHNOLOGIES, INC.
Primus+
Not in Commercial Distribution

  • 10850390007236 ()


  • Biomechanical function analysis system, force-testing, stationary

Simulator II - 10850390007151

A rehabilitation device for upper extremity strength testing and exercise. The dynamometer offers isometric and concentric isotonic modes, as well as many adapters for isolated joint and compound motions.
BTE TECHNOLOGIES, INC.
Sim II 5
In Commercial Distribution

  • 10850390007151 ()


  • Biomechanical function analysis system, force-testing, stationary

Simulator II - 10850390007137

A rehabilitation device for upper extremity strength testing and exercise. The dynamometer offers isometric and concentric isotonic modes, as well as many adapters for isolated joint and compound motions.
BTE TECHNOLOGIES, INC.
Sim II 03
In Commercial Distribution

  • 10850390007137 ()


  • Biomechanical function analysis system, force-testing, stationary

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

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

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

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

Varioguide Hardware (Version G) - 04056481000967

No Description
Brainlab AG
55950-70G
In Commercial Distribution

  • 04056481000967 ()
55950-70G

  • Robotic surgical navigation system
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