Primary Device ID | 08714729353300 |
NIH Device Record Key | 38e77216-b954-44e6-b042-2c2dc3602af3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Rotablator™ Rotational Atherectomy System Console Kit |
Version Model Number | H802220200391 |
Catalog Number | H802220200391 |
Company DUNS | 021717889 |
Company Name | BOSTON SCIENTIFIC 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 | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08714729353300 [Primary] |
MCX | CATHETER, CORONARY, ATHERECTOMY |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2021-04-06 |
Device Publish Date | 2014-09-24 |
08714729719601 | Rotational Atherectomy System |
08714729353300 | Rotational Atherectomy System |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ROTABLATOR 75393589 2217285 Dead/Cancelled |
SCIMED LIFE SYSTEMS, INC. 1997-11-20 |
ROTABLATOR 73650945 1463388 Live/Registered |
E.R. SQUIBB & SONS, INC. 1987-03-23 |