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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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ZeroWire G2 - 00818089022185

OLYMPUS AMERICA, ZEROWIRE G2 PAIR, WITH 27'' ACCESSORIES
Nds Surgical Imaging LLC
90T2099
In Commercial Distribution

  • 00818089022185 ()


  • Medical networking interface unit

Radiance - 00818089021584

AESCULAP CHINA RADIANCE ULTRA 27", DIGITAL SECONDARY, SC-WU27-G1520
Nds Surgical Imaging LLC
90X0697
In Commercial Distribution

  • 00818089021584 ()


  • Image display unit, colour

Radiance - 00818089021560

RADIANCE ULTRA 27", CUSTOM OLYMPUS, DIGITAL SECONDARY, SC-WU27-G1520
Nds Surgical Imaging LLC
90X0658
In Commercial Distribution

  • 00818089021560 ()


  • Image display unit, colour

RADIANCE - 00818089020747

PENTAX, ZEROWIRE G2 RX, DVI, WR-P42-11, FOR 27”
Nds Surgical Imaging LLC
90T2080
In Commercial Distribution

  • 00818089020747 ()


  • Image display unit, colour

RADIANCE - 00818089020730

PENTAX, ZEROWIRE G2 DUO, DVI, SDI, FOR 27”
Nds Surgical Imaging LLC
90T2079
In Commercial Distribution

  • 00818089020730 ()


  • Image display unit, colour

Vision 2 - 00817978020226

Salmonella O Group B O: 4, 5, 27
PRO-LAB, INCORPORATED
PLA022
In Commercial Distribution

  • 00817978020226 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

PreView™ - B6785210660

ACP 2 Level x 27 mm, Low Profile
NEXUS SPINE, L.L.C.
521066
In Commercial Distribution

  • B6785210660 ()

  • Length: 27 Millimeter


  • Spinal fixation plate, non-bioabsorbable

PreView II™ - B6785211510

ACP 2 Level x 27 mm, Swivel Lock
NEXUS SPINE, L.L.C.
521151
In Commercial Distribution

  • B6785211510 ()

  • Length: 27 Millimeter


  • Spinal fixation plate, non-bioabsorbable

LASIK Cannulas - 08175700111539

LASIK Irrigation Cannula, 4 Ports, Curved, 27 Gauge
AURORA SURGICAL, LLC
AS13-1701-27g
In Commercial Distribution

  • 08175700111539 ()
AS13-1701-27g

  • Ophthalmic angular gauge, reusable

Dakota ALIF System - 00840019963046

33 X 27 X 19mm X 0° PEEK-2C
PRECISION SPINE, INC.
69-AM-0019-2C
Not in Commercial Distribution

  • 00840019963046 ()
69-AM-0019-2C

  • Polymeric spinal interbody fusion cage

Dakota ALIF System - 00840019963039

33 X 27 X 17mm X 0° PEEK-2C
PRECISION SPINE, INC.
69-AM-0017-2C
Not in Commercial Distribution

  • 00840019963039 ()
69-AM-0017-2C

  • Polymeric spinal interbody fusion cage

Dakota ALIF System - 00840019963022

33 X 27 X 15mm X 0° PEEK-2C
PRECISION SPINE, INC.
69-AM-0015-2C
Not in Commercial Distribution

  • 00840019963022 ()
69-AM-0015-2C

  • Polymeric spinal interbody fusion cage

Dakota ALIF System - 00840019963015

33 X 27 X 13mm X 0° PEEK-2C
PRECISION SPINE, INC.
69-AM-0013-2C
Not in Commercial Distribution

  • 00840019963015 ()
69-AM-0013-2C

  • Polymeric spinal interbody fusion cage

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

Plateau Spacer System - 00190837046637

Plateau-A Trial, 33 x 27 x 16, 12°
Life Spine, Inc.
116-779
In Commercial Distribution

  • 00190837046637 ()
116-779

  • Polymeric spinal interbody fusion cage
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