FDA.reportPublic FDA data

UE Intubation Stylet

Primary DI
06970283489417
Brand
UE Intubation Stylet
Company
Zhejiang UE Medical Corp
Model
P1
Device description
The product is intended to introduce devices to cavity or tissue.
Published
2024-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
06970283489417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970283489417069702834894176970283489417

GMDN Terms#

Term, Definition table
TermDefinition
Artificial airway stylet, reusableA 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 It is designed to be slightly shorter than the tube to avoid damage to the airway during passage, and is withdrawn after intubation has been completed.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 reusable device.

Contacts#

Phone, Email table
PhoneEmail
+8657687788798export@ueworld.com

Regulatory Flags#

DUNS number
542992969
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06937048207891UE BRONCHO Single-Use BronchoscopesEBS-380C2026-02-26
06937048207907UE BRONCHO Single-Use BronchoscopesEBS-500C2026-02-26
06937048207914UE BRONCHO Single-Use BronchoscopesEBS-600C2026-02-26
06937048207884UE DisplayUE-M10S2026-02-26
16937048207898UE BRONCHO Single-Use BronchoscopesEBS-380C2026-02-26
16937048207904UE BRONCHO Single-Use BronchoscopesEBS-500C2026-02-26
16937048207911UE BRONCHO Single-Use BronchoscopesEBS-600C2026-02-26
06970283489219UESCOPE Single-Use Laryngoscope Blade, Size A1UED-A12024-12-17
06970283489226UESCOPE Single-Use Laryngoscope Blade, Size A0UED-A02024-12-17
06970283489233UESCOPE Single-Use Laryngoscope Blade, Size MA1UED-MA12024-12-17
16970283489216UESCOPE Single-Use Laryngoscope Blade, Size A1UED-A12024-12-17
16970283489223UESCOPE Single-Use Laryngoscope Blade, Size A0UED-A02024-12-17
16970283489230UESCOPE Single-Use Laryngoscope Blade, Size MA1UED-MA12024-12-17
06970283489394UE Intubation StyletP32024-12-17
06970283489400UESCOPE Single-Use Laryngoscope Blade, Size J3J32024-12-17
06970283489424UE Intubation StyletP22024-12-17
06970283483941UE DisplayVL4602022-09-05
06970283481633UESCOPE Disposable Laryngoscope Blade, Size 2UED-22022-09-09
06970283481664UESCOPE Disposable Laryngoscope Blade, Size 3UED-32022-09-09
06970283481695UESCOPE Disposable Laryngoscope Blade, Size 4UED-42022-09-09

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