Rotaglide™ H7493948300170

GUDID 00191506005566

Lubricant

BOSTON SCIENTIFIC CORPORATION

Mechanical atherectomy system, coronary, line-powered
Primary Device ID00191506005566
NIH Device Record Keyb71807b0-637f-4203-bcfd-2e73c5dbf039
Commercial Distribution StatusIn Commercial Distribution
Brand NameRotaglide™
Version Model NumberH7493948300170
Catalog NumberH7493948300170
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100191506005559 [Primary]
GS100191506005566 [Package]
Contains: 00191506005559
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCXCATHETER, CORONARY, ATHERECTOMY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-13
Device Publish Date2023-11-03

On-Brand Devices [Rotaglide™]

08714729847557Lubricant
08714729837619Lubricant
00191506005580Lubricant
00191506005566Lubricant

Trademark Results [Rotaglide]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ROTAGLIDE
ROTAGLIDE
87580548 5677636 Live/Registered
Dairymaster
2017-08-23
ROTAGLIDE
ROTAGLIDE
75507353 2470049 Live/Registered
SCIMED LIFE SYSTEMS, INC.
1998-06-23

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