SwiftSet

GUDID 30884521196777

Topical Skin Adhesive

Covidien LP

Skin-approximation adhesive
Primary Device ID30884521196777
NIH Device Record Key89c44d4e-6763-4913-97ee-04298b007e6f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSwiftSet
Version Model NumberSS6
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

Device Dimensions

Total Volume0.8 Milliliter
Total Volume0.8 Milliliter
Total Volume0.8 Milliliter
Total Volume0.8 Milliliter
Total Volume0.8 Milliliter
Total Volume0.8 Milliliter
Total Volume0.8 Milliliter
Total Volume0.8 Milliliter
Total Volume0.8 Milliliter
Total Volume0.8 Milliliter
Total Volume0.8 Milliliter
Total Volume0.8 Milliliter
Total Volume0.8 Milliliter
Total Volume0.8 Milliliter
Total Volume0.8 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521196773 [Primary]
GS120884521196770 [Package]
Contains: 10884521196773
Package: PACK_OR_INNER_PACK [6 Units]
In Commercial Distribution
GS130884521196777 [Package]
Contains: 20884521196770
Package: CASE [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MPNTissue adhesive for the topical approximation of skin

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2024-05-20
Device Publish Date2017-01-07

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Trademark Results [SwiftSet]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SWIFTSET
SWIFTSET
98705772 not registered Live/Pending
Satori Home Limited
2024-08-19
SWIFTSET
SWIFTSET
97635352 not registered Live/Pending
Satori Home Limited
2022-10-17
SWIFTSET
SWIFTSET
86698111 5365413 Live/Registered
Tech Flo Consulting, LLC
2015-07-20
SWIFTSET
SWIFTSET
86061363 4545274 Live/Registered
Covidien LP
2013-09-11
SWIFTSET
SWIFTSET
76093144 2471641 Live/Registered
Mity-Lite, Inc.
2000-07-19

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