GORE CARDIOFORM ASD Occluder ASD48A

GUDID 00733132636525

GORE CARDIOFORM ASD Occluder 48mm 14Fr

W. L. Gore & Associates, Inc.

Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder
Primary Device ID00733132636525
NIH Device Record Key23dd70cf-f7c0-46b1-a59b-e8f9821d221a
Commercial Distribution StatusIn Commercial Distribution
Brand NameGORE CARDIOFORM ASD Occluder
Version Model NumberASD48A
Catalog NumberASD48A
Company DUNS967358115
Company NameW. L. Gore & Associates, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
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

Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com

Device Dimensions

Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100733132636525 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MLVTranscatheter Septal Occluder

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-15
Device Publish Date2019-08-07

On-Brand Devices [GORE CARDIOFORM ASD Occluder]

00733132636518GORE CARDIOFORM ASD Occluder 44 mm 10Fr
00733132636501GORE CARDIOFORM ASD Occluder 37 mm 10Fr
00733132636495GORE CARDIOFORM ASD Occluder 32 mm 10Fr
00733132636488GORE CARDIOFORM ASD Occluder 27 mm 10Fr
00733132636525GORE CARDIOFORM ASD Occluder 48mm 14Fr

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