Exxcel Soft ePTFE Vascular Graft M002004810150

GUDID 00384409000299

Exxcel Soft ePTFE SW 5/10

MAQUET CARDIOVASCULAR LLC

Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft
Primary Device ID00384409000299
NIH Device Record Key39f818ea-69fc-4dd9-b040-7580b399157b
Commercial Distribution StatusIn Commercial Distribution
Brand NameExxcel Soft ePTFE Vascular Graft
Version Model NumberM002004810150
Catalog NumberM002004810150
Company DUNS022348156
Company NameMAQUET CARDIOVASCULAR LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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

Phone888-880-2874
Emailcssurgery@maquet.com
Phone888-880-2874
Emailcssurgery@maquet.com
Phone888-880-2874
Emailcssurgery@maquet.com
Phone888-880-2874
Emailcssurgery@maquet.com
Phone888-880-2874
Emailcssurgery@maquet.com
Phone888-880-2874
Emailcssurgery@maquet.com
Phone888-880-2874
Emailcssurgery@maquet.com
Phone888-880-2874
Emailcssurgery@maquet.com
Phone888-880-2874
Emailcssurgery@maquet.com
Phone888-880-2874
Emailcssurgery@maquet.com
Phone888-880-2874
Emailcssurgery@maquet.com
Phone888-880-2874
Emailcssurgery@maquet.com
Phone888-880-2874
Emailcssurgery@maquet.com

Device Dimensions

Lumen/Inner Diameter5 Millimeter
Lumen/Inner Diameter5 Millimeter
Length10 Centimeter
Lumen/Inner Diameter5 Millimeter
Length10 Centimeter
Lumen/Inner Diameter5 Millimeter
Length10 Centimeter
Lumen/Inner Diameter5 Millimeter
Length10 Centimeter
Lumen/Inner Diameter5 Millimeter
Length10 Centimeter
Lumen/Inner Diameter5 Millimeter
Length10 Centimeter
Lumen/Inner Diameter5 Millimeter
Length10 Centimeter
Lumen/Inner Diameter5 Millimeter
Length10 Centimeter
Lumen/Inner Diameter5 Millimeter
Length10 Centimeter
Lumen/Inner Diameter5 Millimeter
Length10 Centimeter
Lumen/Inner Diameter5 Millimeter
Length10 Centimeter
Lumen/Inner Diameter5 Millimeter
Length10 Centimeter
Lumen/Inner Diameter5 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100384409000299 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

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