Exxcel Soft ePTFE Vascular Graft M002004810440

GUDID 00384409001456

Exxcel Soft ePTFE SW ST/4/40

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 ID00384409001456
NIH Device Record Key7dcf3552-f3f6-4edc-b64b-02c110c81630
Commercial Distribution StatusIn Commercial Distribution
Brand NameExxcel Soft ePTFE Vascular Graft
Version Model NumberM002004810440
Catalog NumberM002004810440
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 Diameter4 Millimeter
Lumen/Inner Diameter4 Millimeter
Length40 Centimeter
Lumen/Inner Diameter4 Millimeter
Length40 Centimeter
Lumen/Inner Diameter4 Millimeter
Length40 Centimeter
Lumen/Inner Diameter4 Millimeter
Length40 Centimeter
Lumen/Inner Diameter4 Millimeter
Length40 Centimeter
Lumen/Inner Diameter4 Millimeter
Length40 Centimeter
Lumen/Inner Diameter4 Millimeter
Length40 Centimeter
Lumen/Inner Diameter4 Millimeter
Length40 Centimeter
Lumen/Inner Diameter4 Millimeter
Length40 Centimeter
Lumen/Inner Diameter4 Millimeter
Length40 Centimeter
Lumen/Inner Diameter4 Millimeter
Length40 Centimeter
Lumen/Inner Diameter4 Millimeter
Length40 Centimeter
Lumen/Inner Diameter4 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
GS100384409001456 [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

On-Brand Devices [Exxcel Soft ePTFE Vascular Graft]

00384409002460EXXCEL SOFT THIN WALL STR EXT S 10/70/70
00384409002453EXXCEL SOFT THIN WALL STR EXT S 10/50/50
00384409002446EXXCEL SOFT THIN WALL STR EXT S 8/70/70
00384409002439EXXCEL SOFT THIN WALL STR EXT S 8/40/30
00384409002422EXXCEL SOFT THIN WALL STR EXT S 7/70/70
00384409002415EXXCEL SOFT THIN WALL STR EXT S 6/70/70
00384409002408EXXCEL SOFT THIN WALL STR EXT S 6/50/50
00384409002392EXXCEL SOFT THIN WALL STR EXT S 8/80/70
00384409002385EXXCEL SOFT THIN WALL STR EXT S 6/80/60
00384409002378EXXCEL SOFT THIN WALL STR EXT S 8/80/50
00384409002361EXXCEL SOFT THIN WALL STR EXT S 6/80/50
00384409002354EXXCEL SOFT THIN WALL STR EXT S 6/80/30
00384409002347EXXCEL SOFT THIN WALL STR EXT S 6/80/20
00384409002330EXXCEL SOFT THIN WALL STR EXT S 6/70/60
00384409002323EXXCEL SOFT THIN WALL STR EXT S 8/70/50
00384409002316EXXCEL SOFT THIN WALL STR EXT S 6/70/50
00384409002309EXXCEL SOFT THIN WALL STR EXT S 5/70/50
00384409002293EXXCEL SOFT THIN WALL STR EXT S 8/70/30
00384409002286EXXCEL SOFT THIN WALL STR EXT S 6/70/30
00384409002279EXXCEL SOFT THIN WALL STR EXT S 8/70/20
00384409002262EXXCEL SOFT THIN WALL STR EXT S 6/70/20
00384409002255EXXCEL SOFT THIN WALL STR EXT S 8/50/20
00384409002248EXXCEL SOFT THIN WALL STR EXT S 6/50/20
00384409002231EXXCEL SOFT THIN WALL STR EXT S 6/40/30
00384409002224EXXCEL SOFT THIN WALL STR EXT S 8/40/20
00384409002217EXXCEL SOFT THIN WALL STR EXT S 6/40/20
00384409002200EXXCEL SOFT THIN WALL STR EXT S 8/30/12
00384409002194EXXCEL SOFT THIN WALL STR EXT S 8/80/80
00384409002187EXXCEL SOFT THIN WALL STR EXT S 6/80/80
00384409002170EXXCEL SOFT THIN WALL STR EXT S 6/60/60
00384409002163EXXCEL SOFT THIN WALL STR EXT 6/40/40
00384409002156EXXCEL SOFT THIN WALL STR 8/80
00384409002149EXXCEL SOFT THIN WALL STR 7/80
00384409002132EXXCEL SOFT THIN WALL STR 6/80
00384409002125EXXCEL SOFT THIN WALL STR 5/80
00384409002118EXXCEL SOFT THIN WALL STR 10/80
00384409002101EXXCEL SOFT THIN WALL STR 8/70
00384409002095EXXCEL SOFT THIN WALL STR 7/70
00384409002088EXXCEL SOFT THIN WALL STR 6/70
00384409002071EXXCEL SOFT THIN WALL STR 5/70
00384409002064EXXCEL SOFT THIN WALL STR 10/70
00384409002057EXXCEL SOFT THIN WALL STR 6/60
00384409002040EXXCEL SOFT THIN WALL STR 8/50
00384409002033EXXCEL SOFT THIN WALL STR 6/50
00384409002026EXXCEL SOFT THIN WALL STR 10/50
00384409002019EXXCEL SOFT THIN WALL STR 8/40
00384409002002EXXCEL SOFT THIN WALL STR 6/40
00384409001999EXXCEL SOFT THIN WALL STR 10/40
00384409001982EXXCEL SOFT THIN WALL STR 8/30
00384409001975EXXCEL SOFT THIN WALL STR 6/30
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.