SOFIA 88 DA8115ST

GUDID 00842429117705

SOFIA 88 - 115cm

MICROVENTION INC.

Vascular guide-catheter, single-use
Primary Device ID00842429117705
NIH Device Record Key166e158b-e3bc-4a42-b1a8-2b99db08f6a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOFIA 88
Version Model NumberDA8115ST-DAC-US
Catalog NumberDA8115ST
Company DUNS003263105
Company NameMICROVENTION 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(714) 247-8000
Emailcustomerservice@microvention.com
Phone+1(714) 247-8000
Emailcustomerservice@microvention.com
Phone+1(714) 247-8000
Emailcustomerservice@microvention.com
Phone+1(714) 247-8000
Emailcustomerservice@microvention.com
Phone+1(714) 247-8000
Emailcustomerservice@microvention.com
Phone+1(714) 247-8000
Emailcustomerservice@microvention.com
Phone+1(714) 247-8000
Emailcustomerservice@microvention.com
Phone+1(714) 247-8000
Emailcustomerservice@microvention.com
Phone+1(714) 247-8000
Emailcustomerservice@microvention.com
Phone+1(714) 247-8000
Emailcustomerservice@microvention.com
Phone+1(714) 247-8000
Emailcustomerservice@microvention.com
Phone+1(714) 247-8000
Emailcustomerservice@microvention.com
Phone+1(714) 247-8000
Emailcustomerservice@microvention.com
Phone+1(714) 247-8000
Emailcustomerservice@microvention.com
Phone+1(714) 247-8000
Emailcustomerservice@microvention.com
Phone+1(714) 247-8000
Emailcustomerservice@microvention.com
Phone+1(714) 247-8000
Emailcustomerservice@microvention.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100842429117705 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCatheter, percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-23
Device Publish Date2023-06-15

Devices Manufactured by MICROVENTION INC.

00842429108444 - Sofia2024-10-28 Sofia 6F-115cm STR
00842429108451 - Sofia2024-10-28 Sofia 6F-125cm STR
00842429108468 - Sofia2024-10-28 Sofia 6F-131cm STR
00842429108475 - Sofia2024-10-28 Sofia 6F-125cm STR
00842429118092 - Access2024-10-28 Sofia EX 5F - 115cm STR
00842429119396 - Wedge2024-10-28 Wedge XL
00842429108482 - Sofia2024-08-14 Sofia 6F-131cm STR
00842429117705 - SOFIA 882023-06-23SOFIA 88 - 115cm
00842429117705 - SOFIA 882023-06-23 SOFIA 88 - 115cm

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