Primary Device ID | 07392532191251 |
NIH Device Record Key | 53f03760-5662-457e-967d-dfc11cfd68dc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Simplant |
Version Model Number | Version 18 |
Catalog Number | 54500277P18 |
Company DUNS | 764142159 |
Company Name | Dentsply Implants NV |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)531-3481 |
implants-na-cs@dentsplysirona. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07392532191251 [Primary] |
LLZ | System, image processing, radiological |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-02-06 |
Device Publish Date | 2018-05-01 |
07392532209413 | Case Viewer |
07392532208423 | Simplant Editor |
07392532205583 | Case Viewer |
07392532204814 | Simplant Editor |
07392532191251 | Simplant Pro |
07392532191220 | Simplant View |
07392532208416 | Simplant View |
07392532206269 | Simplant Pro |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SIMPLANT 79016792 3171725 Live/Registered |
DENTSPLY Implants NV 2004-10-27 |
SIMPLANT 77848515 3877954 Dead/Cancelled |
WomanCare Global LLC 2009-10-14 |