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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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Integra® - 10381780241478

Integra® Total Foot System K-Wire is used for temporary fixation.
Ascension Orthopedics, Inc.
2228611
In Commercial Distribution

  • M26922286111 ()
  • 10381780241478 ()

  • 3.937in L x .0433in diameter
2228611

  • Orthopaedic guidewire, reusable

Integra® Pyrosphere® - 10381780243625

Instrument Case Base is the bottom portion wherein devices are placed.
Ascension Orthopedics, Inc.
CSA43001
In Commercial Distribution

  • M269CSA430011 ()
  • 10381780243625 ()

  • NA
CSA-430-01

  • Instrument tray, reusable

Integra® - 10381780241508

Integra® Humeral Resurfacing Arthroplasty K-Wire is used for temporary fixation.
Ascension Orthopedics, Inc.
605300230
Not in Commercial Distribution

  • M2696053002301 ()
  • 10381780241508 ()

  • 3.0 mm dia x 230mm L
605 300230

  • Orthopaedic guidewire, reusable

Integra® - 10381780241485

Integra® Total Foot System K-Wire is used for temporary fixation.
Ascension Orthopedics, Inc.
2237811
In Commercial Distribution

  • M26922378111 ()
  • 10381780241485 ()

  • 3.937in L x .0620in diameter
2237811

  • Orthopaedic guidewire, reusable

C&C - D798CCP0

This pad attachment is intended for use in extrusion of teeth.
RELIANCE ORTHODONTIC PRODUCTS INC
CCP
In Commercial Distribution

  • D798CCP0 ()
CCP

  • Orthodontic aligner auxiliary attachment kit

C&C - D798CCO0

Intended use: This oval attachment is used for extrusion of teeth.
RELIANCE ORTHODONTIC PRODUCTS INC
CCO
In Commercial Distribution

  • D798CCO0 ()
CCO

  • Orthodontic aligner auxiliary attachment kit

Romero Large Introducer for Standard Heights - B806RO0005LISH0

Romero Large Introducer for Standard Heights (H is less than 10)
Spineup, Inc.
RO0005LISH
In Commercial Distribution

  • B806RO0005LISH0 ()
RO0005LISH

  • Orthopaedic inorganic implant inserter/extractor, reusable

SENTRY SEDATE-BASIC - 00816711020554

SENTRY SEDATE-BASIC - This is an accessory only; not a medical device
PARKER-HANNIFIN CORPORATION
SENTRY-B
In Commercial Distribution

  • 00816711020554 ()


  • Gas cylinder trolley

NeoHug® - 00812594013416

NeoHug is intended to support, organize or hold non-operating medical devices.
Neotech Products LLC
Assorted - Suction
In Commercial Distribution

  • 00812594012761 ()
  • 00812594013416 ()
N680A-S

  • Frame/rail/pole device holder

NeoHug® - 00812594013409

NeoHug is intended to support, organize or hold non-operating medical devices.
Neotech Products LLC
Smiley Assorted -Suction
In Commercial Distribution

  • 00812594011917 ()
  • 00812594013409 ()
N681A-S

  • Frame/rail/pole device holder
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