GORE BIO-A Fistula Plug FP0616

GUDID H373FP06163

FISTULA PLUG 16MMD 6X9CMT 1PK

W. L. Gore & Associates, Inc.

Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Primary Device IDH373FP06163
NIH Device Record Keyd14e66c0-4569-4293-8f52-f8d6f763e11e
Commercial Distribution StatusIn Commercial Distribution
Brand NameGORE BIO-A Fistula Plug
Version Model NumberFP0616
Catalog NumberFP0616
Company DUNS967358115
Company NameW. L. Gore & Associates, 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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
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(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com

Device Dimensions

Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Device Size Text, specify0
Length9 Centimeter
Outer Diameter16 Millimeter
Device Size Text, specify0
Length9 Centimeter
Outer Diameter16 Millimeter
Device Size Text, specify0
Length9 Centimeter
Outer Diameter16 Millimeter
Device Size Text, specify0
Length9 Centimeter
Outer Diameter16 Millimeter
Device Size Text, specify0
Length9 Centimeter
Outer Diameter16 Millimeter
Device Size Text, specify0
Length9 Centimeter
Outer Diameter16 Millimeter
Device Size Text, specify0
Length9 Centimeter
Outer Diameter16 Millimeter
Device Size Text, specify0
Length9 Centimeter
Outer Diameter16 Millimeter
Device Size Text, specify0
Length9 Centimeter
Outer Diameter16 Millimeter
Device Size Text, specify0
Length9 Centimeter
Outer Diameter16 Millimeter
Device Size Text, specify0
Length9 Centimeter
Outer Diameter16 Millimeter
Device Size Text, specify0
Length9 Centimeter
Outer Diameter16 Millimeter
Device Size Text, specify0
Length9 Centimeter
Outer Diameter16 Millimeter
Device Size Text, specify0
Length9 Centimeter
Outer Diameter16 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100733132605408 [Primary]
HIBCCH373FP06163 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTLMesh, surgical, polymeric

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 Date2017-02-13

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