FDA.reportPublic FDA data

Total Control Introducer™ (TCI)

Primary DI
00860581002639
Brand
Total Control Introducer™ (TCI)
Company
Through The Cords, LLC
Model
000163
Device description
Articulating Introducer with detachable handle, intuitive depth system, 70 CM, 15 Fr, latex free, single use, sterile, fits 6.0 and larger ID tubes
Published
2022-12-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSRStylet, Tracheal Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSRStylet, Tracheal TubeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860581002646PackageGS15Not in Commercial Distribution
00860581002653PackageGS120Not in Commercial Distribution
00860581002639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860581002646008605810026468605810026460860581002646
00860581002653008605810026538605810026530860581002653
00860581002639008605810026398605810026390860581002639

GMDN Terms#

Term, Definition table
TermDefinition
Endotracheal tube introducer, single-useA device designed to help with the insertion of an endotracheal (ET) tube into the airways of a patient during intubation. It is a long, thin, rod-like device, typically angled at the distal end, designed to improve directional control of the endotracheal tube during routine or difficult oral intubations. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
801-917-3851info@ttcmed.com

Regulatory Flags#

DUNS number
080585251
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850059297216Runnels Steerable Introducer™ #4 Oral0010312024-03-22
00850059297063Runnels Steerable Introducer™ #2.5 Oral/Nasal0010912024-10-23
00850059297070Runnels Steerable Introducer™ #2.5 Oral/Nasal0010912024-10-23
00850059297001Runnels Steerable Introducer™ #5 Nasal0010792024-10-22
00850059297032Runnels Steerable Introducer™ #2 Oral/Nasal0010972024-10-22
00850059297094Runnels Steerable Introducer™ #3 Oral/Nasal0010852024-10-22
00850059297124Runnels Steerable Introducer™ DLT (35F/37F)0011092024-10-22
00850059297155Runnels Steerable Introducer™ DLT (39F/41F)0011032024-10-22
00850059297018Runnels Steerable Introducer™ #5 Nasal0010792024-10-22
00850059297049Runnels Steerable Introducer™ #2 Oral/Nasal0010972024-10-22
00850059297100Runnels Steerable Introducer™ #3 Oral/Nasal0010852024-10-22
00850059297131Runnels Steerable Introducer™ DLT (35F/37F)0011092024-10-22
00850059297162Runnels Steerable Introducer™ DLT (39F/41F)0011032024-10-22
00850059297186Runnels Steerable Introducer™ #4 Nasal0010502024-01-26
00850059297223Runnels Steerable Introducer™ #4 Oral0010312024-03-22
00850059297193Runnels Steerable Introducer™ #4 Nasal0010502024-01-26
00860006823207TCI™ Si0009462022-12-07
00860006823238Runnels Steerable Introducer™ (rSI)0010312023-06-09
00860581002608Intuitive Depth Bougie™ (IDB), Coude Tip0001182022-12-07
00860581002660Intuitive Depth Exchange™ Catheter (IDE)0002942022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851232007165RTech REUSABLE INTUBATION STYLET D R BURTON HEALTHCARE, LLCBSR2026-04-28
00851232007172RTech STERILE DISPOSABLE INTUBATION STYLETD R BURTON HEALTHCARE, LLCBSR2026-04-28
00851232007189RTech NON-STERILE DISPOSABLE INTUBATION STYLETD R BURTON HEALTHCARE, LLCBSR2026-04-28
00851232007196J-WAND ADVANTAGE INTUBATION STYLET, NON-STERILED R BURTON HEALTHCARE, LLCBSR2026-04-28
10889483033302SunMedSUNMED, LLCBSR2026-02-18
10889483033319SunMedSUNMED, LLCBSR2026-02-18
10889483033326SunMedSUNMED, LLCBSR2026-02-18
20889483033309SunMedSUNMED, LLCBSR2026-02-18
20889483033316SunMedSUNMED, LLCBSR2026-02-18
20889483033323SunMedSUNMED, LLCBSR2026-02-18
00848530094676AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
00848530094683AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
00848530094690AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
00848530094706AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
10848530094673AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
10848530094680AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
10848530094697AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
10848530094703AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
04250105630442Ambu® SureSight TM Stylet; mediumVBM Medizintechnik GmbHBSR2025-07-02
04250105630459Ambu® SureSight TM Stylet; largeVBM Medizintechnik GmbHBSR2025-07-02
04250105630435Ambu® SureSight TM Stylet; smallVBM Medizintechnik GmbHBSR2025-07-02
14250105630449Ambu® SureSight TM Stylet; mediumVBM Medizintechnik GmbHBSR2025-07-02
14250105630456Ambu® SureSight TM Stylet; largeVBM Medizintechnik GmbHBSR2025-07-02
05055788776246ProVu Video StyletFLEXICARE MEDICAL LIMITEDBSR2025-05-30
05055788776260ProVu Video StyletFLEXICARE MEDICAL LIMITEDBSR2025-05-30
05055788776284ProVu Video StyletFLEXICARE MEDICAL LIMITEDBSR2025-05-30
05055788776307ProVu Video StyletFLEXICARE MEDICAL LIMITEDBSR2025-05-30
00860004198864Stylet – Tracheal Tube/ Bougie CatheterGMMI SDN. BHD.BSR2025-05-23
10860004198861Stylet – Tracheal Tube/ Bougie CatheterGMMI SDN. BHD.BSR2025-05-23
05030267108763UNIVERSAL STYLET BOUGIE (USB) WITHOUT SACHET OF LUBRICANTIntersurgical IncorporatedBSR2025-03-14