FDA.reportPublic FDA data

INTERGUIDE TRACHEAL TUBE INTRODUCER (BOUGIE), SIZE 6FR, OD 2.0 MM

Primary DI
05030267110216
Brand
INTERGUIDE TRACHEAL TUBE INTRODUCER (BOUGIE), SIZE 6FR, OD 2.0 MM
Company
INTERSURGICAL INCORPORATED
Model
8070006
Device description
INTERGUIDE TRACHEAL TUBE INTRODUCER (BOUGIE), SIZE 6FR, OD 2.0 MM
Published
2021-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
05030267110216PackageGS110In Commercial Distribution
05030267108718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05030267110216050302671102165030267110216
05030267108718050302671087185030267108718

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
3154512900support@intersurgicalinc.com

Regulatory Flags#

DUNS number
785952607
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05030267124084ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 0, NEONATE 15M122000051948502025-09-25
05030267124091ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 1, INFANT, 15M122100051948502025-09-25
05030267124107ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 2, PAEDIATRIC, 22F122200051948502025-09-25
05030267123582ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 3, SMALL ADULT, 22F122300051948502025-09-25
05030267124121ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 4, MEDIUM ADULT, 22F122400051948502025-09-25
05030267124077ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 5, LARGE ADULT, 22F122500051948502025-09-25
05030267124138ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 6, EXTRA LARGE ADULT, 22122600051948502025-09-25
05030267165322I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, SMALL ADULT730000151948502025-09-23
05030267165346I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, MEDIUM ADULT730100151948502025-09-23
05030267165360HIGH FLOW NASAL CANNULA WITH ADAPTER, LARGE ADULT730200151948502025-09-23
0503026704595222MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE 519185051918502025-04-16
0503026704588422MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6M519485051948502025-04-16
05030267001804TRACHEOSTOMY MASK, PAEDIATRIC120600012060002025-04-15
05030267098088PREMATURE, NASAL CANNULA WITH CURVED PRONGS AND TUBE, 2.1M 116000011600002025-04-15
0503026716528522MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVE518301051830102025-04-15
00816472022552Nose Clip with Padding143560002025-04-14
0503026716154622mm Compact breathing system21580192025-04-14
0503026716175122mm Compact breathing system21580122025-04-14
05030267166367I-GEL® PLUS ANAESTHESIA, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG890300089030002025-04-14
05030267166466I-GEL® PLUS ANAESTHESIA, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG.890400089040002025-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20889483033309SunMedSUNMED, LLCBSR2026-02-18
20889483033316SunMedSUNMED, LLCBSR2026-02-18
20889483033323SunMedSUNMED, LLCBSR2026-02-18
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
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
10860004198861Stylet – Tracheal Tube/ Bougie CatheterGMMI SDN. BHD.BSR2025-05-23
05030267167678UNIVERSAL STYLET BOUGIE (USB) WITHOUT SACHET OF LUBRICANTIntersurgical IncorporatedBSR2025-03-14
16936881166676Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16936881166683Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16936881166690Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16936881166706Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
06936881166716Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16936881166720Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16944932773414Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16944932773438Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16944932773445Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16944932773452Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16944932773483Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
06970283489394UE Intubation StyletZhejiang UE Medical CorpBSR2024-12-17
06970283489424UE Intubation StyletZhejiang UE Medical CorpBSR2024-12-17
00850059297070Runnels Steerable Introducer™ #2.5 Oral/NasalThrough The Cords, LLCBSR2024-10-23
00850059297018Runnels Steerable Introducer™ #5 NasalThrough The Cords, LLCBSR2024-10-22
00850059297049Runnels Steerable Introducer™ #2 Oral/NasalThrough The Cords, LLCBSR2024-10-22
00850059297100Runnels Steerable Introducer™ #3 Oral/NasalThrough The Cords, LLCBSR2024-10-22
00850059297131Runnels Steerable Introducer™ DLT (35F/37F)Through The Cords, LLCBSR2024-10-22