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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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PLS - 08057432564794

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-630T540
In Commercial Distribution

  • 08057432564794 ()


  • Trans-facet-screw internal spinal fixation system, sterile

PLS - 08057432564770

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-620T540
In Commercial Distribution

  • 08057432564770 ()


  • Trans-facet-screw internal spinal fixation system, sterile

PLS - 08057432564763

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-4100T58
In Commercial Distribution

  • 08057432564763 ()


  • Trans-facet-screw internal spinal fixation system, sterile

PLS - 08057432564756

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-4095T58
In Commercial Distribution

  • 08057432564756 ()


  • Trans-facet-screw internal spinal fixation system, sterile

PLS - 08057432564749

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-4090T58
In Commercial Distribution

  • 08057432564749 ()


  • Trans-facet-screw internal spinal fixation system, sterile

PLS - 08057432564732

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-4085T58
In Commercial Distribution

  • 08057432564732 ()


  • Trans-facet-screw internal spinal fixation system, sterile

PLS - 08057432564725

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-430T58
In Commercial Distribution

  • 08057432564725 ()


  • Trans-facet-screw internal spinal fixation system, sterile

PLS - 08057432564718

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-460T56
In Commercial Distribution

  • 08057432564718 ()


  • Trans-facet-screw internal spinal fixation system, sterile

PLS - 08057432564701

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-460T55
In Commercial Distribution

  • 08057432564701 ()


  • Trans-facet-screw internal spinal fixation system, sterile

PLS - 08057432564695

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-455T55
In Commercial Distribution

  • 08057432564695 ()


  • Trans-facet-screw internal spinal fixation system, sterile

Ace Medical - 00840217906166

Micro Injection Needle Style II 11ga x 9cm Luer Lockhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Ebner Medical, LLC
AA7771109
In Commercial Distribution

  • 00840217906166 ()

  • Length: 9 Centimeter
  • Outer Diameter: 3.048 Millimeter


  • Surgical/emergency suction cannula, non-illuminating, reusable

ASSURE Patient Application - 00840241600214

ASSURE patient app is a component of the ASSURE WCD System and transmits information to CareStation
Kestra Medical Technologies, Inc.
80315-005
In Commercial Distribution

  • 00840241600214 ()
80315-005

  • Medical equipment clinical data interfacing software

2.7mm Trephine Removal - 00811954012694

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=523872#
INTERVENTIONAL SPINE, INC
6008
In Commercial Distribution

  • 00811954012694 ()
6008

  • Bone trephine, reusable

NexxZr™ Plus / W-98-26-NP-C400-SD - 00814356021516

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22141
Not in Commercial Distribution

  • 00814356021516 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-25-NP-C400-SD - 00814356021509

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22140
Not in Commercial Distribution

  • 00814356021509 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-22-NP-C400-SD - 00814356021493

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22139
Not in Commercial Distribution

  • 00814356021493 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-20-NP-C400-SD - 00814356021486

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22138
Not in Commercial Distribution

  • 00814356021486 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-18-NP-C400-SD - 00814356021479

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22137
Not in Commercial Distribution

  • 00814356021479 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-16-NP-C400-SD - 00814356021462

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22136
Not in Commercial Distribution

  • 00814356021462 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-14-NP-C400-SD - 00814356021455

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22135
Not in Commercial Distribution

  • 00814356021455 ()


  • Dental appliance fabrication material, ceramic
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