Primary Device ID | 00884838094857 |
NIH Device Record Key | 4a1811c4-2b06-4db0-b708-a5ec56519951 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DynaCAD |
Version Model Number | 5.0 |
Company DUNS | 009237140 |
Company Name | INVIVO CORPORATION |
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 | true |
Serial Number | false |
Manufacturing Date | false |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00884838094857 [Primary] |
LLZ | System, Image Processing, Radiological |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-08-25 |
Device Publish Date | 2021-08-17 |
00884838103740 - Sentinelle | 2023-03-06 Sentinelle, Biopsy Grid |
00884838115279 - Invivo | 2022-11-30 Kit, Enhanced Access, Bilateral Upgrade consists of Fiducial Marker Block; 3 Grid Plates Enhanced Access-Lateral; 3 Grid Plates |
00884838115309 - Invivo | 2022-11-30 dS Breast 16 Biopsy Pack, 1.5T contains - 4 Lateral Grids Upper dS Breast 16Ch I/T; 4 Medial Grids dS Breast 16CH I/T; MRI Needl |
00884838115255 - Invivo | 2022-11-28 BREAST 7 BIOPSY PACK 1.5T contains - 3 LBS M-L Grid Immobilization Plates; 3 LBS M-L Pillar Immobilization Plates Sterilized; M |
00884838115507 - Sentinelle | 2022-10-24 DS Sentinelle Breast 16CH Coil Kit, 1.5T Consists of 1CH Left and Right Lateral Coils and Medial Plug with box of 10 Sentinelle |
00884838115514 - Sentinelle | 2022-10-24 DS Sentinelle Breast coil, Biopsy Kit 3.0T Consists of 1CH Left and Right Lateral Coils and Medial Plug with box of 10 Sentinell |
00884838105195 - Sentinelle | 2022-10-20 dS 3.0T 4CH Lateral Left |
00884838105201 - Sentinelle | 2022-10-20 dS 3.0T 4CH Lateral Right |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() DYNACAD 87143179 5198702 Live/Registered |
KONINKLIJKE PHILIPS N.V. 2016-08-18 |
![]() DYNACAD 78400932 3080575 Live/Registered |
INVIVO CORPORATION 2004-04-13 |