Sentinel

Primary DI
00863229000004
Brand
Sentinel
Company
BOSTON SCIENTIFIC CORPORATION
Model
CMS15-10C-US
Catalog number
CMS15-10C-US
Device description
No description
Published
2018-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUMTemporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUMTemporary Catheter, Embolic Protection, Transcatheter Intracardiac ProceduresCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN160043000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN160043000Sentinel Cerebral Protection SystemClaret Medical, Inc.2017-06-01PUM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863229000004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863229000004008632290000048632290000040863229000004

GMDN Terms#

Term, Definition table
TermDefinition
Embolic protection filtering guidewireA steerable wire with a filter at its distal end intended to be used to facilitate the placement of diagnostic/interventional vascular devices (e.g., angioplasty balloons, intravascular stents) in the lumen of a blood vessel (coronary, carotid, peripheral), and to provide embolic protection by capturing emboli that may result from the procedure. The filter is deployable (expandable) once inserted distal to the vascular lesion (e.g., atherosclerotic plaque). It typically includes devices for introduction/removal of the guidewire (e.g., deployment/removal sheath), which are not intended to be used as working channels for other interventional devices. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7075289300quality@claretmedical.com

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Expiration date on label
true

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08714729716129Ultraflex™ Esophageal NGM005137002015-09-24
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08714729716143Ultraflex™ Esophageal NGM005137202015-09-24
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