FDA.reportPublic FDA data

TCI™ Si

Primary DI
00860006823207
Brand
TCI™ Si
Company
Through The Cords, LLC
Model
000946
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
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
00860006823214PackageGS15In Commercial Distribution
00860006823221PackageGS120In Commercial Distribution
00860006823207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860006823214008600068232148600068232140860006823214
00860006823221008600068232218600068232210860006823221
00860006823207008600068232078600068232070860006823207

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
8019173851info@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
00860581002639Total Control Introducer™ (TCI)0001632022-12-07
00850059297186Runnels Steerable Introducer™ #4 Nasal0010502024-01-26
00850059297223Runnels Steerable Introducer™ #4 Oral0010312024-03-22
00850059297193Runnels Steerable Introducer™ #4 Nasal0010502024-01-26
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