Primary Device ID | 08714729893431 |
NIH Device Record Key | 13b1803b-5816-4879-bf00-b0844c15f34e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ROTAPRO™ Advancer |
Version Model Number | H74939299A0 |
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 | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
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 | 08714729893431 [Primary] |
MCX | CATHETER, CORONARY, ATHERECTOMY |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2021-04-06 |
Device Publish Date | 2018-07-11 |
08714729424260 - Contour™ | 2024-09-11 Ureteral Stent Set |
08714729462583 - Contour™ | 2024-09-11 Ureteral Stent Set |
08714729462651 - Contour™ | 2024-09-11 Ureteral Stent Set |
08714729462798 - Contour™ | 2024-09-11 Ureteral Stent Set |
00191506020798 - RHYTHMIA HDx™ | 2024-09-11 Ablation Connection Box - IntellaNav StablePoint™ (for INTELLAGEN™) |
00191506020804 - RHYTHMIA HDx™ | 2024-09-11 Ablation Connection Box (for INTELLAGEN™) |
08714729010975 - Connector | 2024-09-09 FOR 7F THROUGH 10F CATHETERS WITH LUER LOCK FITTING Ureteral Catheter Connector |
08714729010982 - Connector | 2024-09-09 FOR 3F THROUGH 6F CATHETERS WITH LUER LOCK FITTING Ureteral Catheter Connector |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ROTAPRO 87059328 not registered Live/Pending |
Boston Scientific Scimed, Inc. 2016-06-03 |