FDA.reportPublic FDA data

BEAR

Primary DI
G043606220
Brand
BEAR
Company
Bear-Ent, LLC
Model
6.06.22
Catalog number
6.06.22
Device description
Universal Speculum Holder, Blade
Published
2023-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JYKHolder, Ear Speculum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYKHolder, Ear SpeculumGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G043606220PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
ENT speculum holderA device intended to be used to secure an ear/nose/throat (ENT) speculum in a fixed position to enable a surgeon to remain hands-free during a surgical intervention. The holder is typically fastened to the side rail of the operating table and can be adjusted to a desired position. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
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
G043200650BEAR2.00.652.00.652022-08-03
G043200660BEAR2.00.662.00.662022-08-03
G043200670BEAR2.00.672.00.672022-08-03
G043200680BEAR2.00.682.00.682022-08-03
G043MLGA4X7AC0BEARMLGA4X7ACMLGA4X7AC2022-05-19
G043MLGA4X7ST0BEARMLGA4X7STMLGA4X7ST2022-05-19
G043MLGO4X7AC0BEARMLGO4X7ACMLGO4X7AC2022-05-19
G043MLGO4X7ST0BEARMLGO4X7STMLGO4X7ST2022-05-19
G043MLGS4X7AC0BEARMLGS4X7ACMLGS4X7AC2022-05-19
G043MLGS4X7ST0BEARMLGS4X7STMLGS4X7ST2022-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250676730015MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbHJYK2025-10-07
04250676730022MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbHJYK2025-10-07
04250676730039MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbHJYK2025-10-07
04250676730046MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbHJYK2025-10-07
04250676734884MENTIO disposable cerumen hookSpiggle & Theis Medizintechnik GmbHJYK2025-10-07
04250676746634MENTIO disposable ear curette/cottonSpiggle & Theis Medizintechnik GmbHJYK2025-10-07
00840183527402BR Surgical, LLCBR Surgical, LLCJYK2024-11-26
G043606200BEARBear-Ent, LLCJYK2023-03-06
G043606230BEARBear-Ent, LLCJYK2023-03-06
G043606280BEARBear-Ent, LLCJYK2022-06-01
B351GC03800mytaMedMytamed, Inc.JYK2021-02-11
B351BGC03800BEARMytamed, Inc.JYK2021-01-18
B351BMN1699V0BEARMytamed, Inc.JYK2021-01-18
04046826110222MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYK2020-09-24
04046826101787MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYK2020-09-24
10381780084648Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYK2018-10-24
24026704526745PILLINGTELEFLEX INCORPORATEDJYK2018-09-15
00821925011663Gyrus ACMIGyrus ACMI, LLCJYK2018-09-07
00821925011670GYRUS ACMI, INCGyrus ACMI, LLCJYK2018-09-07
00821925011687GYRUS ACMI, INCGyrus ACMI, LLCJYK2018-09-07
00821925011694Gyrus ACMIGyrus ACMI, LLCJYK2018-09-07
10381780110866MicroFrance®INTEGRA MICROFRANCEJYK2018-01-12
10381780110873MicroFrance®INTEGRA MICROFRANCEJYK2018-01-12
10381780110897MicroFrance®INTEGRA MICROFRANCEJYK2018-01-12
10381780110910MicroFrance®INTEGRA MICROFRANCEJYK2018-01-12
10381780110835MicroFrance®INTEGRA MICROFRANCEJYK2018-01-12