FDA.reportPublic FDA data

Runnels Steerable Introducer™ DLT (35F/37F)

Primary DI
00850059297124
Brand
Runnels Steerable Introducer™ DLT (35F/37F)
Company
Through The Cords, LLC
Model
001109
Device description
Pre-lubricated articulating introducer with intuitive colored depth system, 86.5 CM, 12 Fr, latex free, single use, sterile, fits 35f, 37f DLT tubes.
Published
2024-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
00850059297131PackageGS15In Commercial Distribution
00850059297148PackageGS120In Commercial Distribution
00850059297124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850059297131008500592971318500592971310850059297131
00850059297148008500592971488500592971480850059297148
00850059297124008500592971248500592971240850059297124

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.

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
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
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

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Primary DI, Brand, Company table
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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
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