ENROUTE Transcarotid Neuroprotection System SR-250-NPS

GUDID 00811311021062

SILK ROAD MEDICAL, INC.

Carotid artery embolic protection system
Primary Device ID00811311021062
NIH Device Record Keyfe2302ab-a898-4864-b5cc-345ab4f8415e
Commercial Distribution StatusIn Commercial Distribution
Brand NameENROUTE Transcarotid Neuroprotection System
Version Model NumberFG12531
Catalog NumberSR-250-NPS
Company DUNS022516829
Company NameSILK ROAD MEDICAL, INC.
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 Latextrue
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
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
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
GS100811311021062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NTETemporary Carotid Catheter For Embolic Capture

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-02
Device Publish Date2023-04-24

On-Brand Devices [ENROUTE Transcarotid Neuroprotection System]

00811311020829Angled-Tip Arterial Sheath Configuration
00811311020775Straight-Tip Arterial Sheath Configuration
00811311020744Angled-Tip Arterial Sheath Configuration
00811311021062FG12531

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