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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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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

Genomadix Cube CYP2C19 - G257ASM001160

Each unit is a box of 5 training kits (containing water).
Genomadix Inc
2
In Commercial Distribution

  • G257ASM001160 ()


  • Nucleic acid amplification mastermix kit IVD

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

Integra®Ti6® - 10381780244905

Integra® The handle is used to assist in orthopedic surgery.
Ascension Orthopedics, Inc.
FS1006
In Commercial Distribution

  • M269FS10061 ()
  • 10381780244905 ()
FS1006

  • Surgical instrument handle, non-torque-limiting

Integra® Ti6® - 10381780244899

The titanium swivel driver handle is useful for inserting small screws.
Ascension Orthopedics, Inc.
FS1005
In Commercial Distribution

  • M269FS10051 ()
  • 10381780244899 ()

  • 4.08 in L
FS1005

  • Surgical instrument handle, non-torque-limiting

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® - 10381780241614

Integra® Humeral Resurfacing Arthroplasty K-Wire is used for temporary fixation.
Ascension Orthopedics, Inc.
605280230
In Commercial Distribution

  • M2696052802301 ()
  • 10381780241614 ()

  • 230 mm L x 2.8 mm dia
605 280230

  • Orthopaedic guidewire, reusable

Integra® - 10381780241515

Integra® Total Foot System K-Wire is used for temporary fixation.
Ascension Orthopedics, Inc.
2227611
Not in Commercial Distribution

  • M26922276111 ()
  • 10381780241515 ()

  • 100 mm L x 1.1 mm dia
2227611

  • Orthopaedic guidewire, 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
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