Total Control Introducer™ (TCI)

GUDID 00860581002639

Articulating Introducer with detachable handle, intuitive depth system, 70 CM, 15 Fr, latex free, single use, sterile, fits 6.0 and larger ID tubes

Through The Cords, LLC

Endotracheal tube introducer, single-use
Primary Device ID00860581002639
NIH Device Record Key1a6c5193-01d8-4016-b170-5cee86553b4b
Commercial Distribution Discontinuation2024-08-13
Commercial Distribution StatusIn Commercial Distribution
Brand NameTotal Control Introducer™ (TCI)
Version Model Number000163
Company DUNS080585251
Company NameThrough The Cords, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone801-917-3851
Emailinfo@ttcmed.com
Phone801-917-3851
Emailinfo@ttcmed.com
Phone801-917-3851
Emailinfo@ttcmed.com
Phone801-917-3851
Emailinfo@ttcmed.com
Phone801-917-3851
Emailinfo@ttcmed.com
Phone801-917-3851
Emailinfo@ttcmed.com
Phone801-917-3851
Emailinfo@ttcmed.com
Phone801-917-3851
Emailinfo@ttcmed.com
Phone801-917-3851
Emailinfo@ttcmed.com
Phone801-917-3851
Emailinfo@ttcmed.com
Phone801-917-3851
Emailinfo@ttcmed.com
Phone801-917-3851
Emailinfo@ttcmed.com
Phone801-917-3851
Emailinfo@ttcmed.com
Phone801-917-3851
Emailinfo@ttcmed.com
Phone801-917-3851
Emailinfo@ttcmed.com
Phone801-917-3851
Emailinfo@ttcmed.com
Phone801-917-3851
Emailinfo@ttcmed.com
Phone801-917-3851
Emailinfo@ttcmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860581002639 [Primary]
GS100860581002646 [Package]
Package: Box [5 Units]
Not in Commercial Distribution
GS100860581002653 [Package]
Contains: 00860581002646
Package: Case [20 Units]
Not in Commercial Distribution

FDA Product Code

BSRStylet, Tracheal Tube

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-15
Device Publish Date2022-12-07

Devices Manufactured by Through The Cords, LLC

00850059297070 - Runnels Steerable Introducer™ #2.5 Oral/Nasal2024-10-31 Pre-lubricated articulating introducer with intuitive colored depth system, 67 CM, 12 Fr, latex free, single use, sterile, fits
00850059297018 - Runnels Steerable Introducer™ #5 Nasal2024-10-30 Pre-lubricated articulating introducer with intuitive colored depth system, 91.5 CM, 15 Fr, latex free, single use, sterile, fit
00850059297049 - Runnels Steerable Introducer™ #2 Oral/Nasal2024-10-30 Pre-lubricated articulating introducer with intuitive colored depth system, 62 CM, 12 Fr, latex free, single use, sterile, fits
00850059297100 - Runnels Steerable Introducer™ #3 Oral/Nasal2024-10-30 Pre-lubricated articulating introducer with intuitive colored depth system, 67 CM, 15 Fr, latex free, single use, sterile, fits
00850059297131 - Runnels Steerable Introducer™ DLT (35F/37F)2024-10-30 Pre-lubricated articulating introducer with intuitive colored depth system, 86.5 CM, 12 Fr, latex free, single use, sterile, fit
00850059297162 - Runnels Steerable Introducer™ DLT (39F/41F)2024-10-30 Pre-lubricated articulating introducer with intuitive colored depth system, 86.5 CM, 15 Fr, latex free, single use, sterile, fit
00850059297223 - Runnels Steerable Introducer™ #4 Oral2024-04-01 Pre-lubricated articulating introducer with intuitive colored depth system, 70 CM, 15 Fr, latex free, single use, sterile, fits
00850059297193 - Runnels Steerable Introducer™ #4 Nasal2024-02-05 Pre-lubricated articulating introducer with intuitive colored depth system, 77 CM, 15 Fr, latex free, single use, sterile, fits

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