FDA.reportPublic FDA data

GlideScope®

Primary DI
00879123007797
Brand
GlideScope®
Company
Verathon Medical (Canada) ULC
Model
Video Baton QC Large
Catalog number
0570-0417
Device description
GlideScope® Video Baton QC Large
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
CCWLaryngoscope, Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10879123007794PackageGS11In Commercial Distribution
30879123007798PackageGS11In Commercial Distribution
00879123007797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1087912300779410879123007794
3087912300779830879123007798
00879123007797008791230077978791230077970879123007797

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical laryngopharyngoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the larynx/oropharynx. It is inserted into the body through the mouth during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle, or the device may allow for direct visualization through the lumen of its shaft/working channel. This device may be equipped with a channel or mechanism allowing the introduction of air to prevent misting of the distal end. This is a reusable device.

Regulatory Flags#

DUNS number
243738320
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840432200063CystoView™Essential Configuration with Holder and QuickConne0270-12032026-05-15
00840432200117CystoView™CystoView™ Monitor0570-04652026-05-15
00840432200308CystoView™Clamp Kit Configuration with Holder and QuickConne0270-12022026-05-15
00840432200315CystoView™Clamp Kit Configuration with QuickConnect™ Cable0270-12012026-05-15
00840432200322CystoView™Monitor with QuickConnect™ Cable0270-12002026-05-15
00879123006561GlideScope®Video Baton 2.0 Large (3-4)0570-03822022-12-08
00879123009012BFlex™BFlex™ 2 SamplePro™0574-02632026-05-29
00879123009340GlideScope®GlideScope® Core™ 10 FHD Essential Configuration0270-1212-FHD2026-05-29
00879123009357GlideScope®GlideScope® Core™ 15 FHD Essential Configuration0270-1213-FHD2026-05-29
00840432200056Verathon®Verathon® Essential Workstation0800-07002026-05-28
00840432200001CFlex™Single-Use Cystoscope, Standard Deflection0570-04552026-05-15
00840432200018CFlex™Single-Use Cystoscope, Reverse Deflection0570-04592026-05-15
00879123007841GlideScope®ClearFit™ Video Baton0570-04252025-08-01
00879123008381GlideScope®ClearFit™ Hyperangle 3 Cover0574-02422025-08-01
00879123008398GlideScope®ClearFit™ Hyperangle 4 Cover0574-02432025-08-01
00879123008428GlideScope®ClearFit™ Miller 2 Cover0574-02472025-08-01
00879123008442GlideScope®ClearFit™ MAC 2 Cover0574-02442025-08-01
00879123008459GlideScope®ClearFit™ MAC 3 Cover0574-02452025-08-01
00879123008466GlideScope®ClearFit™ MAC 4 Cover0574-02462025-08-01
00879123007612GlideScope®GlideScope® Go™ 2 Monitor Configuration0270-11862025-08-01

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