AccessGUDID - app超級簽名銷售經理電報yoernet）.asa

GUDID

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

Pressure,30-40 mmHg (3)
9x12mm (2)
12 Blocks, 3 Firing Pads, 1 Syr. Calibra Ceram w/10 mix tips, 1 bottle Prime&Bond elect, 25 flocked app. tips, 1 disp. well, 1 syr. Coupling Agent w/25 disp. app. needles, 1 Stain & Glaze Kit (1)
2 Tooth Colored Syringes, 2 Blue Syringes, 1 bottle each Xeno®, P&B, and activator, 25 Mixing Tips, 25 Intraoral Tips, 10 Endo Intaoral Tips, 1 Disp Well, 50 App Tips, 50 Root Canal Tips (1)
20 Compula® Tips-5 each shade A1, A2, A3, A3.5 (0.25g each), 20 Adhesive Unit Doses, 1 Syringe Tooth Cond Gel, 1 Compules® Tips Gun, 1 Unit Dose Holder, 25 App Needles, 50 App Tips (1)
5 Syringes Cement, 5 Syringes Try-In Paste, 1 Bottle Adhesive, 1 Dispensing Well, 50 Tips, 1 Light Protection Cover, 1 Syringe Silane Coupling Agent, 1 Syringe Tooth Cond Gel, 25 App Needles (1)
6 Compules® Tips, 1 Compules® Tips Gun, 3 Compula® Tips, Enhance® Finishers, 6 Bond Unit Doses, 1 Unit Dose Holder, 6 Flocked Applicator Tips, 1 Syringe Tooth Cond Gel, 25 App Tips (1)
8 TPH3 Syringes, 5 P&B Unit Doses, 1 Prisma Gloss Fine and Extrafine Syringe, 1 syringe Tooth Cond Gel, 1 shade guide, 25 polishing cups, 1 mandrel, Enhance Discs, Cups, & Points, 5 App Tips (1)
No size - Software as a Medical Device (1)
UNIV (1)

Device Class

Implantable

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NexxZr™ Plus / W-98-14-NP-C200-SD - 00814356021233

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#

Company Name: SAGEMAX BIOCERAMICS, INC

Version or Model: W-22113

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

00814356021233 (Primary)

Catalog Number:
GMDN Terms:

Dental appliance fabrication material, ceramic

PLS - 08057432565388

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#

Company Name: SINTEA PLUSTEK SRL

Version or Model: PLS-760T58

Commercial Distribution Status: In Commercial Distribution
Device IDs:

08057432565388 (Primary)

Catalog Number:
GMDN Terms:

Trans-facet-screw internal spinal fixation system, sterile

PLS - 08057432565371

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#

Company Name: SINTEA PLUSTEK SRL

Version or Model: PLS-760T57

Commercial Distribution Status: In Commercial Distribution
Device IDs:

08057432565371 (Primary)

Catalog Number:
GMDN Terms:

Trans-facet-screw internal spinal fixation system, sterile

PLS - 08057432565357

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#

Company Name: SINTEA PLUSTEK SRL

Version or Model: PLS-760T55

Commercial Distribution Status: In Commercial Distribution
Device IDs:

08057432565357 (Primary)

Catalog Number:
GMDN Terms:

Trans-facet-screw internal spinal fixation system, sterile

PLS - 08057432565340

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#

Company Name: SINTEA PLUSTEK SRL

Version or Model: PLS-760T540

Commercial Distribution Status: In Commercial Distribution
Device IDs:

08057432565340 (Primary)

Catalog Number:
GMDN Terms:

Trans-facet-screw internal spinal fixation system, sterile

PLS - 08057432565333

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#

Company Name: SINTEA PLUSTEK SRL

Version or Model: PLS-755T540

Commercial Distribution Status: In Commercial Distribution
Device IDs:

08057432565333 (Primary)

Catalog Number:
GMDN Terms:

Trans-facet-screw internal spinal fixation system, sterile

PLS - 08057432565326

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#

Company Name: SINTEA PLUSTEK SRL

Version or Model: PLS-660T58

Commercial Distribution Status: In Commercial Distribution
Device IDs:

08057432565326 (Primary)

Catalog Number:
GMDN Terms:

Trans-facet-screw internal spinal fixation system, sterile

PLS - 08057432565319

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#

Company Name: SINTEA PLUSTEK SRL

Version or Model: PLS-655T58

Commercial Distribution Status: In Commercial Distribution
Device IDs:

08057432565319 (Primary)

Catalog Number:
GMDN Terms:

Trans-facet-screw internal spinal fixation system, sterile

PLS - 08057432565302

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#

Company Name: SINTEA PLUSTEK SRL

Version or Model: PLS-650T58

Commercial Distribution Status: In Commercial Distribution
Device IDs:

08057432565302 (Primary)

Catalog Number:
GMDN Terms:

Trans-facet-screw internal spinal fixation system, sterile

PLS - 08057432565296

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#

Company Name: SINTEA PLUSTEK SRL

Version or Model: PLS-645T58

Commercial Distribution Status: In Commercial Distribution
Device IDs:

08057432565296 (Primary)

Catalog Number:
GMDN Terms:

Trans-facet-screw internal spinal fixation system, sterile

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