AccessGUDID - APP企业签名销售经理（电报JDiosmdmm）.vuy

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

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)
SIZE 2, TYPE 0 (1)
UNIV (1)
Ø5.8X4.0(2.0)mm (1)

Device Class

Class II (2172)

Implantable

Show Filters

PLS - 08057432564725

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-430T58

Commercial Distribution Status: In Commercial Distribution
Device IDs:

08057432564725 (Primary)

Catalog Number:
GMDN Terms:

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#

Company Name: SINTEA PLUSTEK SRL

Version or Model: PLS-460T56

Commercial Distribution Status: In Commercial Distribution
Device IDs:

08057432564718 (Primary)

Catalog Number:
GMDN Terms:

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#

Company Name: SINTEA PLUSTEK SRL

Version or Model: PLS-460T55

Commercial Distribution Status: In Commercial Distribution
Device IDs:

08057432564701 (Primary)

Catalog Number:
GMDN Terms:

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#

Company Name: SINTEA PLUSTEK SRL

Version or Model: PLS-455T55

Commercial Distribution Status: In Commercial Distribution
Device IDs:

08057432564695 (Primary)

Catalog Number:
GMDN Terms:

Trans-facet-screw internal spinal fixation system, sterile

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#

Company Name: SAGEMAX BIOCERAMICS, INC

Version or Model: W-22141

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

00814356021516 (Primary)

Catalog Number:
GMDN Terms:

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#

Company Name: SAGEMAX BIOCERAMICS, INC

Version or Model: W-22140

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

00814356021509 (Primary)

Catalog Number:
GMDN Terms:

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#

Company Name: SAGEMAX BIOCERAMICS, INC

Version or Model: W-22139

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

00814356021493 (Primary)

Catalog Number:
GMDN Terms:

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#

Company Name: SAGEMAX BIOCERAMICS, INC

Version or Model: W-22138

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

00814356021486 (Primary)

Catalog Number:
GMDN Terms:

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#

Company Name: SAGEMAX BIOCERAMICS, INC

Version or Model: W-22137

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

00814356021479 (Primary)

Catalog Number:
GMDN Terms:

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#

Company Name: SAGEMAX BIOCERAMICS, INC

Version or Model: W-22136

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

00814356021462 (Primary)

Catalog Number:
GMDN Terms:

Dental appliance fabrication material, ceramic

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