Surgipro II XX-5191J

GUDID 20884521137421

Monofilament Polypropylene

Covidien LP

Polyolefin suture, monofilament
Primary Device ID20884521137421
NIH Device Record Key001b6057-b5be-404b-b22d-2a69b21936b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgipro II
Version Model NumberXX-5191J
Catalog NumberXX-5191J
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
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
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

Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0
Length36 Inch
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
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
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
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
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
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
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
GS110884521137424 [Primary]
GS120884521137421 [Package]
Contains: 10884521137424
Package: CASE [12 Units]
In Commercial Distribution

FDA Product Code

GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-09-23
Device Publish Date2015-09-03

On-Brand Devices [Surgipro II]

10884521155572Monofilament Polypropylene
20884521196329Monofilament Polypropylene,MV-175-8,D/A,1x Blue Strand
20884521154671Monofilament Polypropylene
20884521137377Monofilament Polypropylene
20884521136448Monofilament Polypropylene
20884521133348Monofilament Polypropylene
20884521133331Monofilament Polypropylene
20884521118574Monofilament Polypropylene
20884521215495Monofilament Polypropylene, MVF-175-8, D/A, 2x Blue Strands
20884521212425Monofilament Polypropylene, C-13, 1x Blue Strand
20884521212395Monofilament Polypropylene, P-10, 1x Blue Strand
20884521136240Monofilament Polypropylene
20884521136233Monofilament Polypropylene
20884521112831Monofilament Polypropylene
20884521039787Monofilament Polypropylene,KV-7,D/A,1x Blue Strand with Firm PTFE Pledget 7x3x1.5mm
20884521039299Monofilament Polypropylene
20884521037943Monofilament Polypropylene
20884521196817Monofilament Polypropylene,CV-23,D/A,1x Blue Strand with Soft PTFE Pledget 9.5x4.8x1.5mm
20884521195636Monofilament Polypropylene
20884521143118Monofilament Polypropylene
20884521140995Monofilament Polypropylene
20884521136691Monofilament Polypropylene
20884521136509Monofilament Polypropylene
20884521133324Monofilament Polypropylene,KV-15,D/A,1x Blue Strand
20884521196367Monofilament Polypropylene,CV-13,D/A,1x Blue Strand
20884521181127Monofilament Polypropylene,C-18,1x Blue Strand with Beads and Collars
20884521177625Monofilament Polypropylene,CV-23,D/A,1x Blue Strand
20884521154435Monofilament Polypropylene,CV-1,D/A,1x Blue Strand with Soft PTFE Pledget 3x3x1.5mm
20884521137421Monofilament Polypropylene
20884521136806Monofilament Polypropylene
20884521136622Monofilament Polypropylene
20884521132365Monofilament Polypropylene
20884521118581Monofilament Polypropylene
20884521115863Monofilament Polypropylene,CV-337,D/A,1x Blue Strand
20884521039282Monofilament Polypropylene
20884521037813Monofilament Polypropylene
20884521037776Monofilament Polypropylene
20884521037639Monofilament Polypropylene
20884521780313Monofilament Polypropylene
20884521780290Monofilament Polypropylene
20884521780276Monofilament Polypropylene
20884521758688Monofilament Polypropylene
20884521758633Monofilament Polypropylene
20884521758558Monofilament Polypropylene
20884521758541Monofilament Polypropylene
20884521758534Monofilament Polypropylene
20884521758527Monofilament Polypropylene
20884521758510Monofilament Polypropylene
20884521758503Monofilament Polypropylene
20884521758497Monofilament Polypropylene

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.