FDA.report

Intubating Stylet OD 5.0mm (15Ch) 405mm

Primary DI
05055788729624
Brand
Intubating Stylet OD 5.0mm (15Ch) 405mm
Company
FLEXICARE MEDICAL LIMITED
Model
038-967-050U
Published
2020-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
BSRStylet, Tracheal Tube

Product Code Classifications

CodeDeviceSpecialtyClass
BSRStylet, Tracheal TubeAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055788729624PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055788729624050557887296245055788729624

GMDN Terms

TermDefinition
Artificial airway stylet, single-useA sterile, long, stiffening wire/rod designed for insertion within the lumen of an artificial airway tube (e.g., endotracheal tube, bronchial tube) to stiffen and/or maintain the shape of the tube to facilitate introduction (intubation). It is designed to be slightly shorter than the tube to avoid damage to the airway during passage, and is withdrawn after intubation has been completed. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
504406273
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05055788776246ProVu Video Stylet038-995-065U038-995-065U2025-05-30
05055788776260ProVu Video Stylet038-995-070U038-995-070U2025-05-30
05055788776284ProVu Video Stylet038-995-075U038-995-075U2025-05-30
05055788776307ProVu Video Stylet038-995-080U038-995-080U2025-05-30
05055788721499Flexicare040-836U2024-11-21
05055788721550Flexicare040-835U2024-11-21
05055788721802Flexicare040-831U2024-11-21
15055788722462BriteBlade Pro Evo Single-Use Fiber Optic Miller 4040-764U2024-08-07
15055788722486BriteBlade Pro Evo Single-Use Fiber Optic Miller 3040-763U2024-08-07
15055788722509BriteBlade Pro Evo Single-Use Fiber Optic Miller 2040-762U2024-08-07
15055788722523BriteBlade Pro Evo Single-Use Fiber Optic Miller 1040-761U2024-08-07
15055788722561BriteBlade Pro Evo Single-Use Fiber Optic Mac 4040-754U2024-08-07
15055788722585BriteBlade Pro Evo Single-Use Fiber Optic Mac 2040-753U2024-08-07
15055788722608BriteBlade Pro Evo Single-Use Fiber Optic Mac 1040-752U2024-08-07
15055788722622BriteBlade Pro Evo Single-Use Fiber Optic Mac 1040-751U2024-08-07
05055931127888Flexicare032-10-180LU2024-07-17
05055931127895Flexicare032-10-181LU2024-07-17
05055931127901Flexicare032-10-182LU2024-07-17
05055931127918Flexicare010-762LU2024-07-17
05055931104162ProVu040-08-0420U2024-06-24

Other Devices Sharing Product Codes

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