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

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

Device Class

Implantable

Show Filters

NexxZr™ Plus / W-98-10-NP-C300-SD - 00814356021325

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-22122

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

00814356021325 (Primary)

Catalog Number:
GMDN Terms:

Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-35-NP-C200-SD - 00814356021318

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-22121

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

00814356021318 (Primary)

Catalog Number:
GMDN Terms:

Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-30-NP-C200-SD - 00814356021301

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-22120

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

00814356021301 (Primary)

Catalog Number:
GMDN Terms:

Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-26-NP-C200-SD - 00814356021295

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-22119

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

00814356021295 (Primary)

Catalog Number:
GMDN Terms:

Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-25-NP-C200-SD - 00814356021288

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-22118

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

00814356021288 (Primary)

Catalog Number:
GMDN Terms:

Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-22-NP-C200-SD - 00814356021271

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-22117

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

00814356021271 (Primary)

Catalog Number:
GMDN Terms:

Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-20-NP-C200-SD - 00814356021264

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-22116

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

00814356021264 (Primary)

Catalog Number:
GMDN Terms:

Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-18-NP-C200-SD - 00814356021257

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-22115

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

00814356021257 (Primary)

Catalog Number:
GMDN Terms:

Dental appliance fabrication material, ceramic

NexxZr™ Plus / W-98-16-NP-C200-SD - 00814356021240

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-22114

Commercial Distribution Status: Not in Commercial Distribution
Device IDs:

00814356021240 (Primary)

Catalog Number:
GMDN Terms:

Dental appliance fabrication material, ceramic

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

GSO GS1 Spacer - M9935023080

Spacerhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=71318#

Company Name: UNIFIED SPINE, LLC

Version or Model: 502308

Commercial Distribution Status: In Commercial Distribution
Device IDs:

M9935023080 (Primary)

Device Sizes:

Height: 8 Millimeter

Catalog Number:
GMDN Terms:

Orthopaedic bone fixation plate spacer

2.7mm Trephine Removal - 00811954012694

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=523872#

Company Name: INTERVENTIONAL SPINE, INC

Version or Model: 6008

Commercial Distribution Status: In Commercial Distribution
Device IDs:

00811954012694 (Primary)

Catalog Number: 6008
GMDN Terms:

Bone trephine, reusable

Disposable EMG needle electrodes - 18054655015154

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=680752#

Company Name: SPES MEDICA SPA

Version or Model: TFDN452501

Commercial Distribution Status: In Commercial Distribution
Device IDs:

18054655015154 (Primary)
08054655015157 (Unit of Use)

Catalog Number:
GMDN Terms:

Electromyographic needle electrode, single-use

UTM-RT - 38053326009113

UTM ROOM TEMP. 1 ML W/O APP Medium for Virus, Chlamydia, Mycoplasma and Ureaplasma specimens

Company Name: COPAN ITALIA SPA

Version or Model: 3C030N.HL

Commercial Distribution Status: In Commercial Distribution
Device IDs:

58053326009117 (Package)
38053326009113 (Primary)
08053326009112 (Unit of Use)

Catalog Number: 3C030N.HL
GMDN Terms:

General specimen container IVD, additive/medium

UTM-RT - 38053326008970

UTM ROOM TEMP.3 ML W/O APP Medium For Virus, Chlamydia, Mycoplasma and Ureaplasma Specimens

Company Name: COPAN ITALIA SPA

Version or Model: 330C.HL

Commercial Distribution Status: In Commercial Distribution
Device IDs:

58053326008974 (Package)
38053326008970 (Primary)
08053326008979 (Unit of Use)

Catalog Number: 330C.HL
GMDN Terms:

General specimen container IVD, additive/medium

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

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