FDA.reportPublic FDA data

BEAR

Primary DI
B351BGC03800
Brand
BEAR
Company
Mytamed, Inc.
Model
GC0380
Catalog number
GC0380
Device description
Shea Ear Speculum Holder, Complete
Published
2021-01-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
B351BGC03800PrimaryHIBCC0

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
015903922
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
B351BMLGA4X6AC0BEARMLGA4X6ACMLGA4X6AC2021-02-09
B351BMLGA4X6ST0BEARMLGA4X6STMLGA4X6ST2021-02-09
B351BMLGA4X7AC0BEARMLGA4X7ACMLGA4X7AC2021-02-09
B351BMLGA4X7ST0BEARMLGA4X7STMLGA4X7ST2021-02-09
B351BMLGO4X6AC0BEARMLGO4X6ACMLGO4X6AC2021-02-09
B351BMLGO4X6ST0BEARMLGO4X6STMLGO4X6ST2021-02-09
B351BMLGO4X7AC0BEARMLGO4X7ACMLGO4X7AC2021-02-09
B351BMLGO4X7ST0BEARMLGO4X7STMLGO4X7ST2021-02-09
B351BMLGS4X6AC0BEARMLGS4X6ACMLGS4X6AC2021-02-09
B351BMLGS4X7AC0BEARMLGS4X7ACMLGS4X7AC2021-02-09
B351MLGA4X7AC0mytaMedMLGA4X7ACMLGA4X7AC2021-02-09
B351MLGO4X7AC0mytaMedMLGO4X7ACMLGO4X7AC2021-02-09
B351MLGO4X7ST0mytaMedMLGO4X7STMLGO4X7ST2021-02-09
B351MLGS4X7AC0mytaMedMLGS4X7ACMLGS4X7AC2021-02-09
B351MLGA4X7ST0mytaMedMLGA4X7STMLGA4X7ST2020-12-14
B351BMLGS4X6ST0BEARMLGS4X6STMLGS4X6ST2020-05-13
B351BMLGS4X7ST0BEARMLGS4X7STMLGS4X7ST2020-05-13
B351MLGS4X7ST0mytaMedMLGS4X7STMLGS4X7ST2020-05-13
B351MLGA4X6AC0mytaMedMLGA4X6ACMLGA4X6AC2018-02-16
B351MLGA4X6ST0mytaMedMLGA4X6STMLGA4X6ST2018-02-16

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
G043606220BEARBear-Ent, LLCJYK2023-03-06
G043606230BEARBear-Ent, LLCJYK2023-03-06
G043606280BEARBear-Ent, LLCJYK2022-06-01
B351GC03800mytaMedMytamed, Inc.JYK2021-02-11
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