Novafil 8886 4028-31

GUDID 20884521099514

Monofilament Polybutester

Covidien LP

Polyester suture, non-bioabsorbable, monofilament
Primary Device ID20884521099514
NIH Device Record Key3a032376-d02b-4636-b51c-1990db65a301
Commercial Distribution StatusIn Commercial Distribution
Brand NameNovafil
Version Model Number8886 4028-31
Catalog Number8886 4028-31
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

Device Dimensions

Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0
Length30 Inch
Device Size Text, specify0

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521099517 [Primary]
GS120884521099514 [Package]
Contains: 10884521099517
Package: CASE [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 Date2015-08-30

On-Brand Devices [Novafil]

10884521100633Monofilament Polybutester
20884521100913Monofilament Polybutester
20884521100753Monofilament Polybutester
20884521100739Monofilament Polybutester
20884521118383Monofilament Polybutester
20884521118437Monofilament Polybutester,DX-19,1x Blue Strand
20884521118420Monofilament Polybutester
20884521101040Monofilament Polybutester
20884521101019Monofilament Polybutester
20884521100982Monofilament Polybutester
20884521100975Monofilament Polybutester
20884521100968Monofilament Polybutester
20884521100876Monofilament Polybutester
20884521100852Monofilament Polybutester
20884521584638Monofilament Polybutester, DX-13, 1x Clear Strand
20884521164854Monofilament Polybutester
20884521163574Monofilament Polybutester
20884521133386Monofilament Polybutester
20884521118444Monofilament Polybutester,DX-11,1x Blue Strand
20884521118413Monofilament Polybutester,CV-11,D/A,1x Blue Strand
20884521118406Monofilament Polybutester
20884521118390Monofilament Polybutester
20884521118369Monofilament Polybutester
20884521118352Monofilament Polybutester
20884521118345Monofilament Polybutester
20884521118338Monofilament Polybutester
20884521118321Monofilament Polybutester
20884521118314Monofilament Polybutester
20884521101064Monofilament Polybutester
20884521101057Monofilament Polybutester
20884521101026Monofilament Polybutester
20884521100999Monofilament Polybutester
20884521100906Monofilament Polybutester
20884521100890Monofilament Polybutester
20884521100883Monofilament Polybutester
20884521100869Monofilament Polybutester
20884521100838Monofilament Polybutester
20884521100821Monofilament Polybutester
20884521100814Monofilament Polybutester
20884521100807Monofilament Polybutester
20884521100791Monofilament Polybutester
20884521100777Monofilament Polybutester
20884521100760Monofilament Polybutester
20884521100722Monofilament Polybutester
20884521100708Monofilament Polybutester
20884521100692Monofilament Polybutester
20884521100685Monofilament Polybutester
20884521100661Monofilament Polybutester
20884521100654Monofilament Polybutester
20884521100647Monofilament Polybutester

Trademark Results [Novafil]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NOVAFIL
NOVAFIL
77015117 3271226 Live/Registered
Nova Sports USA, Inc.
2006-10-05
NOVAFIL
NOVAFIL
76416566 not registered Dead/Abandoned
SLEEP INNOVATIONS INC.
2002-05-23
NOVAFIL
NOVAFIL
73409843 1301418 Live/Registered
American Cyanamid Company
1983-01-17

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