WEB Aneurysm Embolization System FGA15090-001

GUDID 00856956005558

WEB 27 SLS 9

SEQUENT MEDICAL, INC.

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Primary Device ID00856956005558
NIH Device Record Key25bc3a20-f367-4dab-b399-a550d88f9d2a
Commercial Distribution StatusIn Commercial Distribution
Brand NameWEB Aneurysm Embolization System
Version Model NumberW2-9-S
Catalog NumberFGA15090-001
Company DUNS796807340
Company NameSEQUENT 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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com
Phone949.830.9600
Emailcustomerserviceus@sequentmedical.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS100856956005558 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OPRIntrasaccular Flow Disruption Device

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-08-15
Device Publish Date2019-04-01

On-Brand Devices [WEB Aneurysm Embolization System]

00856956005985WEB 27 SL 9x4
00856956005978WEB 27 SL 8x3
00856956005961WEB 27 SL 11x9
00856956005954WEB 27 SL 11x8
00856956005947WEB 27 SL 11x7
00856956005930WEB 27 SL 11x6
00856956005923WEB 27 SL 10x8
00856956005916WEB 27 SL 10x7
00856956005909WEB 27 SL 10x6
00856956005893WEB 27 SL 10x5
00856956005886WEB 27 SL 9x8
00856956005879WEB 27 SL 9x7
00856956005862WEB 27 SL 9x6
00856956005855WEB 27 SL 9x5
00856956005848WEB 27 SL 8x7
00856956005831WEB 27 SL 8x6
00856956005824WEB 27 SL 8x5
00856956005817WEB 27 SL 8x4
00856956005572WEB 27 SLS 11
00856956005565WEB 27 SLS 10
00856956005558WEB 27 SLS 9
00856956005541WEB 27 SLS 8
00854111006167WEB 21 SL 7x6
00854111006150WEB 21 SL 7x5
00854111006143WEB 21 SL 7x4
00854111006136WEB 21 SL 7x3
00854111006129WEB 21 SL 6x6
00854111006112WEB 21 SL 6x5
00854111006105WEB 21 SL 6x4
00854111006099WEB 21 SL 6x3
00854111006082WEB 21 SL 5x5
00854111006075WEB 21 SL 5x4
00854111006068WEB 21 SL 5x3
00854111006051WEB 21 SL 4x4
00854111006044WEB 21 SL 4x3
00854111006037WEB 21 SLS 7
00854111006020WEB 21 SLS 6
00854111006013WEB 21 SLS 5
00854111006006WEB 21 SLS 4

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