FDA.reportPublic FDA data

BEAR

Primary DI
G043MLGA4X7AC0
Brand
BEAR
Company
Bear-Ent, LLC
Model
MLGA4X7AC
Catalog number
MLGA4X7AC
Device description
Fiberoptic Light Cable, 7.5', ACMI to ACMI
Published
2022-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EQHSource, Carrier, Fiberoptic Light
FCWLight Source, Fiberoptic, Routine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EQHSource, Carrier, Fiberoptic LightEar, Nose, Throat1
FCWLight Source, Fiberoptic, RoutineGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G043MLGA4X7AC0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic light cableA flexible fibreoptic cable that is designed to transport cold light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fibreoptic bundle is protected within a sheath and can be made of either glass or plastic fibres. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fibreoptic bundle. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Hydrogen Peroxide"", ""Ethylene Oxide""]"
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide

Regulatory Flags#

DUNS number
123551586
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G043111500BEAR1.11.501.11.502026-07-08
G043111510BEAR1.11.511.11.512026-07-08
G043111520BEAR1.11.521.11.522026-07-08
G043111540BEAR1.11.541.11.542026-07-08
G043111550BEAR1.11.551.11.552026-07-08
G043111560BEAR1.11.561.11.562026-07-08
G043111570BEAR1.11.571.11.572026-07-08
G043111580BEAR1.11.581.11.582026-07-08
G043111590BEAR1.11.591.11.592026-07-08
G043111600BEAR1.11.601.11.602026-07-08
G04320061G0GEIZ2.00.61.G2.00.61.G2026-05-26
G04320062G0GEIZ2.00.62.G2.00.62.G2026-05-26
G04320065G0GEIZ2.00.65.G2.00.65.G2026-05-26
G04320067G0GEIZ2.00.67.G2.00.67.G2026-05-26
G04320068G0GEIZ2.00.68.G2.00.68.G2026-05-26
G043200600BEAR2.00.602.00.602022-08-03
G043200610BEAR2.00.612.00.612022-08-03
G043200620BEAR2.00.622.00.622022-08-03
G043200630BEAR2.00.632.00.632022-08-03
G043200640BEAR2.00.642.00.642022-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421953MillenniumAvalign Technologies, Inc.EQH2026-07-23
00198506090868ELMED INCORPORATEDELMED INCORPORATEDEQH2026-05-18
00198506086250ELMED INCORPORATEDELMED INCORPORATEDEQH2025-10-20
00190776413347MillenniumAvalign Technologies, Inc.EQH2025-10-09
14026704933065PILLINGTELEFLEX INCORPORATEDEQH2025-04-28
14026704933041PILLINGTELEFLEX INCORPORATEDEQH2025-03-19
14026704933058PILLINGTELEFLEX INCORPORATEDEQH2025-03-19
10840199515995Fiberoptic Dual End CableKOROS U.S.A., INC.EQH2024-12-31
10840199516008Fiberoptic Light PortKOROS U.S.A., INC.EQH2024-12-31
10840199516015Fiberoptic Light PortKOROS U.S.A., INC.EQH2024-12-31
00198506061028ELMED INCORPORATEDELMED INCORPORATEDEQH2024-09-05
10381780539902MicroFrance®INTEGRA MICROFRANCEEQH2024-06-05
10381780539940MicroFrance®INTEGRA MICROFRANCEEQH2024-06-05
10381780540342MicroFrance®INTEGRA MICROFRANCEEQH2024-06-05
10381780539896MicroFrance®INTEGRA MICROFRANCEEQH2024-05-29
10381780540250MicroFrance®INTEGRA MICROFRANCEEQH2024-05-29
10381780540281MicroFrance®INTEGRA MICROFRANCEEQH2024-05-29
10381780540311MicroFrance®INTEGRA MICROFRANCEEQH2024-05-29
14026704921208PILLINGTELEFLEX INCORPORATEDEQH2024-02-13
14026704921314PILLINGTELEFLEX INCORPORATEDEQH2024-02-13
00192896116269Sontec Operating Laryngoscope Light GuideSONTEC INSTRUMENTS, INC.EQH2024-01-22
10845854040423CONMEDConmed CorporationEQH2023-12-05
14026704916877PILLINGTELEFLEX INCORPORATEDEQH2023-11-03
14026704916907PILLINGTELEFLEX INCORPORATEDEQH2023-11-03
M6339982060JEDMEDJEDMED INSTRUMENT COMPANYEQH2023-02-03
00862658000333Fiberoptics Technology INCFIBEROPTICS TECHNOLOGY, INC.EQH2023-01-25
00862658000340Fiberoptics Technology INCFIBEROPTICS TECHNOLOGY, INC.EQH2023-01-25
00842180155176ELMEDELMED INCORPORATEDEQH2023-01-10
00842180156821ELMEDELMED INCORPORATEDEQH2023-01-10
00842180155190ELMEDELMED INCORPORATEDEQH2023-01-09