FDA.report

BEAR

Primary DI
G043BV34000
Brand
BEAR
Company
Bear-Ent, LLC
Model
BV3400
Catalog number
BV3400
Device description
Flexible ENT Rhinolaryngoscope, 3.4 x 300mm
Published
2022-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EOBNasopharyngoscope (Flexible Or Rigid)

Product Code Classifications

CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G043BV34000PrimaryHIBCC0

GMDN Terms

TermDefinition
Flexible fibreoptic nasopharyngoscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the nasopharynx (the upper part of the throat behind the nose). It is inserted through a nostril during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This is a reusable device.

Sterilization Methods

Method
Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide;Peracetic Acid
High-level Disinfectant;Hydrogen Peroxide;Peracetic Acid

Regulatory Flags

DUNS number
123551586
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
G04360200G0GEIZ6.02.00.G6.02.00.G2026-03-05
G04360201G0GEIZ6.02.01.G6.02.01.G2026-03-05
G04360202G0GEIZ6.02.02.G6.02.02.G2026-03-05
G04360203G0GEIZ6.02.03.G6.02.03.G2026-03-05
G04360204G0GEIZ6.02.04.G6.02.04.G2026-03-05
G04362076B0BEAR6.20.76.B6.20.76.B2026-02-03
G043615080BEAR6.15.086.15.082026-01-19
G043615090BEAR6.15.096.15.092026-01-19
G043615100BEAR6.15.106.15.102026-01-19
G043606000BEAR6.06.006.06.002025-07-08
G043606010BEAR6.06.016.06.012025-07-08
G043606020BEAR6.06.026.06.022025-07-08
G043606040BEAR6.06.046.06.042025-07-08
G043606050BEAR6.06.056.06.052025-07-08
G043606060BEAR6.06.066.06.062025-07-08
G043606070BEAR6.06.076.06.072025-07-08
G043606080BEAR6.06.086.06.082025-07-08
G043606090BEAR6.06.096.06.092025-07-08
G043606100BEAR6.06.106.06.102025-07-08
G043PD005010BEARPD005.01PD005.012025-06-23

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00850042909010ProsidioProsidio LLCEOB2026-01-16
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00848657076883AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
00848657076890AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
00848657077712AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EOB2026-01-15
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04961333255245VIVIDEOHOYA CORPORATIONEOB2025-12-19
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00850042909089ProsidioProsidio LLCEOB2025-12-05
00850042909096ProsidioProsidio LLCEOB2025-12-05
00850042909102ProsidioProsidio LLCEOB2025-12-05
00850042909119ProsidioProsidio LLCEOB2025-12-05
00850042909126ProsidioProsidio LLCEOB2025-12-05
00850042909133ProsidioProsidio LLCEOB2025-12-05
00850042909140ProsidioProsidio LLCEOB2025-12-05
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00850042909171ProsidioProsidio LLCEOB2025-12-05
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00850042909829ProsidioProsidio LLCEOB2025-12-05