ENROUTE Transcarotid Stent SR-0920-CS

GUDID 00811311020485

9 mm X 20 mm

SILK ROAD MEDICAL, INC.

Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent
Primary Device ID00811311020485
NIH Device Record Keye84c2aa1-7e35-4c9e-b38c-56650858b46d
Commercial Distribution StatusIn Commercial Distribution
Brand NameENROUTE Transcarotid Stent
Version Model NumberSR-0920-CS
Catalog NumberSR-0920-CS
Company DUNS022516829
Company NameSILK ROAD MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Customer Support Contacts

Phone1-855-410-8227
Emailcustomerservice@silkroadmed.com
Phone1-855-410-8227
Emailcustomerservice@silkroadmed.com
Phone1-855-410-8227
Emailcustomerservice@silkroadmed.com
Phone1-855-410-8227
Emailcustomerservice@silkroadmed.com
Phone1-855-410-8227
Emailcustomerservice@silkroadmed.com
Phone1-855-410-8227
Emailcustomerservice@silkroadmed.com
Phone1-855-410-8227
Emailcustomerservice@silkroadmed.com
Phone1-855-410-8227
Emailcustomerservice@silkroadmed.com
Phone1-855-410-8227
Emailcustomerservice@silkroadmed.com
Phone1-855-410-8227
Emailcustomerservice@silkroadmed.com
Phone1-855-410-8227
Emailcustomerservice@silkroadmed.com
Phone1-855-410-8227
Emailcustomerservice@silkroadmed.com
Phone1-855-410-8227
Emailcustomerservice@silkroadmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100811311020485 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NIMStent, Carotid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-10-17
Device Publish Date2016-07-28

On-Brand Devices [ENROUTE Transcarotid Stent]

0081131102053910 mm X 40 mm
0081131102052210 mm X 30 mm
0081131102051510 mm X 20 mm
008113110205089 mm X 40 mm
008113110204929 mm X 30 mm
008113110204859 mm X 20 mm
008113110204788 mm X 40 mm
008113110204618 mm X 30 mm
008113110204548 mm X 20 mm
008113110204477 mm X 40 mm
008113110204307 mm X 30 mm
008113110204237 mm X 20 mm
008113110204166 mm X 40 mm
008113110204096 mm X 30 mm
008113110203936 mm X 20 mm
008113110203865 mm X 40 mm
008113110203795 mm X 30 mm
008113110203625 mm X 20 mm
0081131102132110-7mm x 40mm
0081131102131410-8mm x 40mm
0081131102130710-8mm x 30mm
008113110212919-7mm x 40mm
008113110212849-7mm x 30mm
008113110212778-6mm x 40mm
008113110212608-6mm x 30mm

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