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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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Dakota ALIF System - 00840019963008

33 X 27 X 11mm X 0° PEEK-2C
PRECISION SPINE, INC.
69-AM-0011-2C
Not in Commercial Distribution

  • 00840019963008 ()
69-AM-0011-2C

  • Polymeric spinal interbody fusion cage

Dakota ALIF System - 00840019961844

33 X 27 X 19mm X 0° PEEK
PRECISION SPINE, INC.
69-AM-0019
In Commercial Distribution

  • 00840019961844 ()
69-AM-0019

  • Polymeric spinal interbody fusion cage

Dakota ALIF System - 00840019961837

33 X 27 X 17mm X 0° PEEK
PRECISION SPINE, INC.
69-AM-0017
In Commercial Distribution

  • 00840019961837 ()
69-AM-0017

  • Polymeric spinal interbody fusion cage

Dakota ALIF System - 00840019961820

33 X 27 X 15mm X 0° PEEK
PRECISION SPINE, INC.
69-AM-0015
In Commercial Distribution

  • 00840019961820 ()
69-AM-0015

  • Polymeric spinal interbody fusion cage

Dakota ALIF System - 00840019961813

33 X 27 X 13mm X 0° PEEK
PRECISION SPINE, INC.
69-AM-0013
In Commercial Distribution

  • 00840019961813 ()
69-AM-0013

  • Polymeric spinal interbody fusion cage

Dakota ALIF System - 00840019961806

33 X 27 X 11mm X 0° PEEK
PRECISION SPINE, INC.
69-AM-0011
In Commercial Distribution

  • 00840019961806 ()
69-AM-0011

  • Polymeric spinal interbody fusion cage

A-FIT® - E53581472700001

A-FIT® 2. MOLAR LWR RGT SZ 27
Gc Orthodontics America Inc.
81-4727-0000
In Commercial Distribution

  • E53581472700001 ()
81-4727-0000

  • Orthodontic metal band

A-FIT® - E53581462700001

A-FIT® 1. MOLAR LWR RGT SZ 27
Gc Orthodontics America Inc.
81-4627-0000
In Commercial Distribution

  • E53581462700001 ()
81-4627-0000

  • Orthodontic metal band

A-FIT® - E53581372700001

A-FIT® 2. MOLAR LWR LFT SZ 27
Gc Orthodontics America Inc.
81-3727-0000
In Commercial Distribution

  • E53581372700001 ()
81-3727-0000

  • Orthodontic metal band

Bioplate® - M384P4SB04270

Straight Plate - Ø2.0 mm - 4 hole - 27 mm
Bioplate, Inc.
P4SB-04-27
In Commercial Distribution

  • M384P4SB04270 ()

  • Length: 27 Millimeter
P4SB-04-27

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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