PTFE Polymer Pledgets VPG36FE

GUDID 20884521550688

Nonabsorbable Pledgets, 10x Firm Pledgets 3x6x1.85mm

Covidien LP

Polyester suture, non-bioabsorbable, multifilament
Primary Device ID20884521550688
NIH Device Record Key2e455b80-72cf-4be4-b8c0-2a6eedf77e11
Commercial Distribution StatusIn Commercial Distribution
Brand NamePTFE Polymer Pledgets
Version Model NumberVPG36FE
Catalog NumberVPG36FE
Company DUNS058614483
Company NameCovidien LP
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 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(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *None;
Special Storage Condition, SpecifyBetween 0 and 0 *None;
Special Storage Condition, SpecifyBetween 0 and 0 *None;
Special Storage Condition, SpecifyBetween 0 and 0 *None;
Special Storage Condition, SpecifyBetween 0 and 0 *None;
Special Storage Condition, SpecifyBetween 0 and 0 *None;
Special Storage Condition, SpecifyBetween 0 and 0 *None;
Special Storage Condition, SpecifyBetween 0 and 0 *None;
Special Storage Condition, SpecifyBetween 0 and 0 *None;

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521550681 [Primary]
GS120884521550688 [Package]
Contains: 10884521550681
Package: PACK_OR_INNER_PACK [36 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GATSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-02-05
Device Publish Date2017-06-23

On-Brand Devices [PTFE Polymer Pledgets]

20884521103174Nonabsorbable Pre-punched Pledgets,5x Firm PTFE Pledgets 9.5x4.8x1.5mm
20884521550701Nonabsorbable Pre-punched Pledgets, 10x Firm Pledgets 4.5x6x1.85mm
20884521104645Nonabsorbable Pre-punched Pledgets,10x Soft PTFE Pledgets 3x7x1.5mm
20884521104638Nonabsorbable Pre-punched Pledgets,5x Soft PTFE Pledgets 9.5x4.8x1.5mm
20884521104614Nonabsorbable Pre-punched Pledgets,10x Firm PTFE Pledgets 3x7x1.5mm
20884521103181Nonabsorbable Pre-punched Pledgets,10x Firm PTFE Pledgets 3x3x1.5mm
20884521550718Nonabsorbable Pledgets, 10x Soft Pledgets 4.5x6x1.65mm
20884521550695Nonabsorbable Pledgets, 10x Soft Pledgets 3x6x1.65mm
20884521550688Nonabsorbable Pledgets, 10x Firm Pledgets 3x6x1.85mm

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