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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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Fastlok 6mm X 23mm - 05060267134325

No Description
XIROS LTD
102-1380
In Commercial Distribution

  • 05060267134325 ()
n/a

  • Tendon/ligament bone anchor, non-bioabsorbable

Poly-Tape 30mm x 800mm - 05060267131812

No Description
XIROS LTD
102-1083
In Commercial Distribution

  • 05060267131812 ()
n/a

  • Surgical support tape, non-bioabsorbable
  • Polyester suture, non-bioabsorbable, multifilament

8mm x 23mm Fastlok - 05060267130112

No Description
XIROS LTD
102-1381
In Commercial Distribution

  • 05060267130112 ()
n/a

  • Tendon/ligament bone anchor, non-bioabsorbable

6mm x 23mm Fastlok - 05060267130099

No Description
XIROS LTD
102-1380
In Commercial Distribution

  • 05060267130099 ()
n/a

  • Tendon/ligament bone anchor, non-bioabsorbable

CALIBRATED 2.5MM X 250MM - 00880304550025

No Description
Biomet Orthopedics, LLC
27575
In Commercial Distribution

  • 00880304550025 ()

  • 2.5MM X 250MM
27575

  • Fluted surgical drill bit, single-use

X FIX DYNAFIX SYSTEM - 00880304529267

No Description
Biomet Orthopedics, LLC
13120
In Commercial Distribution

  • 00880304529267 ()

  • 1.6 MM Ø 350 MM LENGTH
13120

  • External orthopaedic fixation system, single-use

X FIX DYNAFIX SYSTEM - 00880304529199

No Description
Biomet Orthopedics, LLC
13130
In Commercial Distribution

  • 00880304529199 ()

  • 2.0 MM Ø 350 MM LENGTH
13130

  • External orthopaedic fixation system, single-use

RANGE CHECK X ll - 14987562460257

Range Check X ll
SYSMEX CORPORATION
130-4003-0
Not in Commercial Distribution

  • 14987562460257 ()

  • Total Volume: 2 Milliliter


  • Full blood count IVD, control

RANGE CHECK X lll - 14987562460387

Range Check X lll 24X3.0ML WBC/RBC/PLT
SYSMEX CORPORATION
218981
Not in Commercial Distribution

  • 14987562460387 ()

  • Total Volume: 3 Milliliter


  • Full blood count IVD, control

Celebrity X 4 Wheel - 00606509300018

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.
Pride Mobility Products Corp
S4401/SC4401
In Commercial Distribution

  • 00606509300018 ()
N/A

  • Assistive scooter, electric-motor-driven

Celebrity X 3 Wheel - 00606509300001

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.
Pride Mobility Products Corp
S4001/SC4001
In Commercial Distribution

  • 00606509300001 ()
N/A

  • Assistive scooter, electric-motor-driven

.062" x 6" K-Wire - 00811954012830

No Description
INTERVENTIONAL SPINE, INC
6022
In Commercial Distribution

  • 00811954012830 ()
6022

  • General internal orthopaedic fixation system implantation kit

.045" x 6" K-Wire - 00811954012823

No Description
INTERVENTIONAL SPINE, INC
6021
In Commercial Distribution

  • 00811954012823 ()
6021

  • General internal orthopaedic fixation system implantation kit

.045" x 4" K-Wire - 00811954012625

No Description
INTERVENTIONAL SPINE, INC
6001
In Commercial Distribution

  • 00811954012625 ()
6001

  • General internal orthopaedic fixation system implantation kit

.062" x 6" Stylet - 00811954012922

No Description
INTERVENTIONAL SPINE, INC
6032
In Commercial Distribution

  • 00811954012922 ()
6032

  • General internal orthopaedic fixation system implantation kit

.045" x 6" Stylet - 00811954012915

No Description
INTERVENTIONAL SPINE, INC
6031
In Commercial Distribution

  • 00811954012915 ()
6031

  • General internal orthopaedic fixation system implantation kit

Clik™ X MRI - 08714729905325

Anchor
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-4319
In Commercial Distribution

  • 08714729905325 ()


  • Analgesic spinal cord electrical stimulation system

CoverEdge™ X 32 - 08714729832690

70cm 4x8 Surgical Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-8352-70
In Commercial Distribution

  • 08714729832690 ()

  • 70 cm Length


  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection

CoverEdge™ X 32 - 08714729832683

50cm 4x8 Surgical Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-8352-50
In Commercial Distribution

  • 08714729832683 ()

  • 50 cm Length


  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection

25 X 25 COVERSLIPS - 00810119678256

No Description
BIOGENEX LABORATORIES
XT122-YQK
In Commercial Distribution

  • 00810119678256 ()
XT122-YQK

  • Microscope slide coverslip IVD
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